U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON :

1

44–045 cc 1998

S. HRG. 105–180

RADIOACTIVE FALLOUT FROM NUCLEAR TESTINGAT NEVADA TEST SITE, 1950–60

HEARINGBEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON APPROPRIATIONS

UNITED STATES SENATEONE HUNDRED FIFTH CONGRESS

FIRST SESSION

SPECIAL HEARING

Printed for the use of the Committee on Appropriations

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/senate

For sale by the U.S. Government Printing OfficeSuperintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0–16–057149–9

(II)

COMMITTEE ON APPROPRIATIONS

TED STEVENS, Alaska, ChairmanTHAD COCHRAN, MississippiARLEN SPECTER, PennsylvaniaPETE V. DOMENICI, New MexicoCHRISTOPHER S. BOND, MissouriSLADE GORTON, WashingtonMITCH MCCONNELL, KentuckyCONRAD BURNS, MontanaRICHARD C. SHELBY, AlabamaJUDD GREGG, New HampshireROBERT F. BENNETT, UtahBEN NIGHTHORSE CAMPBELL, ColoradoLARRY CRAIG, IdahoLAUCH FAIRCLOTH, North CarolinaKAY BAILEY HUTCHISON, Texas

ROBERT C. BYRD, West VirginiaDANIEL K. INOUYE, HawaiiERNEST F. HOLLINGS, South CarolinaPATRICK J. LEAHY, VermontDALE BUMPERS, ArkansasFRANK R. LAUTENBERG, New JerseyTOM HARKIN, IowaBARBARA A. MIKULSKI, MarylandHARRY REID, NevadaHERB KOHL, WisconsinPATTY MURRAY, WashingtonBYRON DORGAN, North DakotaBARBARA BOXER, California

STEVEN J. CORTESE, Staff DirectorLISA SUTHERLAND, Deputy Staff Director

JAMES H. ENGLISH, Minority Staff Director

SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, ANDEDUCATION, AND RELATED AGENCIES

ARLEN SPECTER, Pennsylvania, ChairmanTHAD COCHRAN, MississippiSLADE GORTON, WashingtonCHRISTOPHER S. BOND, MissouriJUDD GREGG, New HampshireLAUCH FAIRCLOTH, North CarolinaLARRY E. CRAIG, IdahoKAY BAILEY HUTCHISON, Texas

TOM HARKIN, IowaERNEST F. HOLLINGS, South CarolinaDANIEL K. INOUYE, HawaiiDALE BUMPERS, ArkansasHARRY REID, NevadaHERB KOHL, WisconsinPATTY MURRAY, Washington

Majority Professional StaffCRAIG A. HIGGINS and BETTILOU TAYLOR

Minority Professional StaffMARSHA SIMON

Administrative SupportJIM SOURWINE

(III)

C O N T E N T S

PageOpening remarks of Senator Arlen Specter ........................................................... 1Opening remarks of Senator Tom Harkin ............................................................. 2Prepared statement of Senator Harry Reid ........................................................... 4Prepared statement of Senator Patty Murray ....................................................... 3Opening remarks of Senator Larry Craig .............................................................. 6

Prepared statement .......................................................................................... 6Atmospheric tests .................................................................................................... 7Statement of Hon. Richard D. Klausner, M.D., Director, National Cancer

Institute, Department of Health and Human Services ..................................... 8Prepared statement .......................................................................................... 10

Statement of Joseph Lynn Lyon, M.D., M.P.H., professor, Department ofFamily and Preventive Medicine, University of Utah School of Medicine ...... 17

Prepared statement .......................................................................................... 20No funding for study ............................................................................................... 25Statement of Jan Beyea, Ph.D., senior scientist, Consulting in the Public

Interest .................................................................................................................. 26Prepared statement .......................................................................................... 28

Institute of Medicine ............................................................................................... 34Statement of Timothy Connor, associate director, Energy Research Founda-

tion ........................................................................................................................ 34Prepared statement .......................................................................................... 37

Followup study ......................................................................................................... 41Statement of Andrea McGuire, M.D., staff physician, Veterans Administration

Hospital, Des Moines, IA ..................................................................................... 42Prepared statement .......................................................................................... 43

Tests .......................................................................................................................... 44Followup studies not made ..................................................................................... 47Remarks of Senator Slade Gorton .......................................................................... 52Letter from Dr. Richard D. Klausner ..................................................................... 58Letters from Senator Tom Daschle ........................................................................ 58Isotope ....................................................................................................................... 59Statement of Arjun Makhijani, coauthor, article, ‘‘Bulletin of Atomic Sci-

entists’’ .................................................................................................................. 60Prepared statement of Senator Dirk Kempthorne ................................................ 63Prepared statement of Peter G. Crane .................................................................. 63

(1)

RADIOACTIVE FALLOUT FROM NUCLEARTESTING AT NEVADA TEST SITE, 1950–60

WEDNESDAY, OCTOBER 1, 1997

U.S. SENATE,SUBCOMMITTEE ON LABOR, HEALTH AND HUMANSERVICES, AND EDUCATION, AND RELATED AGENCIES,

COMMITTEE ON APPROPRIATIONS,Washington, DC.

The subcommittee met at 9:04 a.m., in room SD–192, DirksenSenate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Specter, Gorton, Craig, Faircloth, Harkin,Reid, and Murray.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL CANCER INSTITUTE

STATEMENT OF RICHARD D. KLAUSNER, M.D., DIRECTOR

OPENING REMARKS OF SENATOR SPECTER

Senator SPECTER. We will begin this hearing, which focuses onthe findings of the National Cancer Institute report on radioactivefallout from nuclear testing at the Nevada Test Site in the 1950’sand 1960’s. Dr. Richard Klausner, the Director NCI, will begin thehearing, with the principal investigators of this study, Mr. BruceWachholz and Mr. Andre Bouville, available to answer questions.Then we will have four witnesses who will evaluate the NCI hear-ing on a number of grounds.

Atmospheric nuclear bomb testing in Nevada yielded significantamounts of radioactive fallout. In 1982 Congress passed legislationdirecting HHS to develop methods of estimating the varieties of ex-posure to the American people, to assess thyroid doses received bythe individuals from across the Nevada desert and individuals allthe way across the country who were impacted by the Nevada test,and to assess the risks of thyroid cancers from these exposures.

This is a very important hearing. We had planned on the sub-committee to do the hearing earlier, but it was impossible to sched-ule it before October 1. This falls on the first day of the new fiscalyear and we have a meeting on our conference report for Labor,Health, Human Services, and Education.

The subcommittee will ask you, Dr. Klausner—your full state-ment will be made part of the record, as will all the statements—if you can limit your testimony opening to 5 minutes, and we willask the witnesses to speak 3 minutes, limiting the rounds of ques-

2

tioning, depending on how many Senators arrive, to 3 minutes aswell.

I regret the time constraints, but I say we do have to completeaction on this legislation for important reasons, including fundingthe National Cancer Institute.

My distinguished ranking member, Senator Harkin.

OPENING REMARKS OF SENATOR TOM HARKIN

Senator HARKIN. Thank you, Chairman Specter, for your leader-ship, for working to convene this hearing on an issue of great im-portance to the people of my State and the country. I am sorryabout the time constraints because I think this needs a full hear-ing, and there probably has to be some follow-up hearings on thisissue and the issue of other possible health effects from radioactivefallout from nuclear testing in the 1950’s.

We have a number of expert witnesses. Dr. Richard Klausner ofthe National Cancer Institute, I thank him for being here. I alsowant to welcome and thank Dr. Andrea McGuire for coming fromIowa for the hearing today. Dr. McGuire is an oncologist from DesMoines who will provide both a professional and personal perspec-tive about this issue.

This morning we are here to get answers, to try to get to thetruth. The report being released today by the National Cancer In-stitute is an important step forward. The NCI study details thehealth impact of iodine-131, a radioactive isotope spread across theUnited States by the 90 above-ground nuclear weapons tests con-ducted in Nevada during the 1950’s. These tests exposed millionsof Americans, particularly children, to large amounts of radioactiveiodine-131, which accumulates in the thyroid gland and has beenlinked to thyroid cancer.

Hot spots where the iodine-131 fallout was greatest includedmany areas far away from Nevada, including New England and theMidwest. Due to the character of iodine-131, those exposed to thehighest concentrations were those who drank large amounts ofmilk from cows that grazed in fields with large fallout. Becausetheir thyroids are smaller and still growing, children were mostvulnerable.

Hot spots were identified as receiving 5 to 16 rads or higher ofexposure to iodine–131, with children being exposed to a risk of upto 10 times higher. To put that in perspective, Federal standardsfor nuclear power plants require that protective action be taken for15 rads. Or to compare it another way, over 115 million curies ofiodine-131 were released in the U.S. above-ground tests. 7.3 millioncuries were released from the Chernobyl disaster.

This issue hits very close to home for me. In the 1950’s I wasgrowing up in south central Iowa, a small town. Along with manyIowans, I lived in hot spots detailed by the NCI study. And, likemany of my neighbors, I drank milk from cows that grazed in thefields.

My family has a history of thyroid problems, my brother Chuck,myself. And I think Dr. McGuire will testify about what’s happenedin her family.

When it comes to the Government and nuclear testing, historyshows the problem has not just been a fallout of radiation, but a

3

holdout of facts. Information has come to light that officials of theU.S. Government were aware that fallout from nuclear blastswould contaminate areas that were hundreds, even thousands, ofmiles away.

An article by Pat Ortmeyer and Arjun Makhijani which will ap-pear in the upcoming issue of the Bulletin of Atomic Scientists doc-uments some of this in chilling detail. Start first with the first nu-clear test in New Mexico in July of 1945. The so-called Trinity testresulted in one hot spot all the way in Indiana. How do we knowthat? Corn husks from that area were used as packaging materialfor Kodak film, and a month after the 1945 test consumers startedcomplaining about fogged film. A physicist at Eastman Kodaklooked into it and uncovered the cause: The corn husks were radio-actively contaminated.

Now fast forward 6 years to the first nuclear test in Nevada.After a snowfall, the geiger counters at the Kodak plant in Roch-ester, New York, registered readings 25 times above normal. Kodakcomplained to the Atomic Energy Commission and that Govern-ment agency agreed to give Kodak advanced information on futuretests, including ‘‘expected distribution of radioactive material inorder to anticipate local contamination.’’

In fact, the Government warned the entire photographic industryand provided maps and forecasts of potential contamination.Where, I ask, were the maps for dairy farmers? Where were thewarnings to parents of children in these areas?

So here we are, Mr. Chairman. The Government protected rollsof film, but not the lives of our kids. There is something wrongwith this picture.

Now, the NCI study has attracted a lot of attention, and that isnot surprising from a report detailing exposure to millions of Amer-icans. However, there is also a controversy over the manner inwhich the study was conducted. Several organizations and many ofmy constituents have expressed concern over the apparent delay inthe release of the study, and I appreciate that Dr. Klausner is hereto shed light on that.

I believe there are three areas we need to explore: First, whatare the facts concerning the preparation and release of the NCI re-port and why did it take 15 years to complete? Second, what arethe next scientific steps in investigating radioactive fallout fromatomic weapons testing? What other fallout was there that couldhave affected us in terms of childhood leukemia and bone cancer?

Last, what are the health policy impacts of the NCI study? Whatshould concerned citizens do if they live in a high-risk area? Whatshould the Federal Government communicate to physicians andother public health officials? What should be the role for the Centerfor Disease Control and Prevention in alerting public health offi-cials around the country?

Last, we should get to the bottom of why, why the Governmentalerted the photographic industry? Why did they do that when theyhad all the information about hot spots and fallout, and yet theydid not warn the people of this country about the dangers inherentin radioactive fallout, especially iodine-131?

Mr. Chairman, I did not mean to take so long. But I believe thishearing is crucial to getting at the bottom of this and to beginning

4

a process, hopefully, of alerting public health officials and othersaround the country as to just what should be done. And I think weought to get to the bottom, as I said, of what was our Government’srole in not alerting the public during the 1950’s and early 1960’s.

Mr. Chairman, thank you.Senator SPECTER. Thank you very much, Senator Harkin.For the members who have just arrived, I had announced earlier

that Senator Harkin and I have a responsibility on the conference.We are going to have to conclude the hearing in 1 hour. Ordinarilywe move ahead on—while it is not the practice of many commit-tees, we do allow opening statements. But I would ask that thosebe waived this morning so that we can proceed with the hearing.

We are going to give Dr. Klausner 5 minutes and the 4 witnesses3. Senator Craig may be able to stay longer. We may have to recon-vene the hearing and go into it in more detail. But as I said earlier,this is the first day of the new fiscal year and we are under con-straints to get a conference report done. We are meeting on thatwith House Members, so we have that very substantial time con-straint.

PREPARED STATEMENT OF SENATOR REID

Senator REID. Mr. Chairman, may I ask unanimous consent thatmy full statement be made part of the record?

Senator SPECTER. Absolutely, Senator Reid.[The statement follows:]

PREPARED STATEMENT OF SENATOR HARRY REID

HEALTH RISKS OF ATMOSPHERIC NUCLEAR TESTING

The National Cancer Institute was asked to respond to legislation requiring avalid and credible assessment of exposure of U.S. citizens to radioactive Iodine-131resulting from fallout from atmospheric testing of nuclear weapons.

It is no longer surprising that many American citizens were placed at risk by at-mospheric testing.

The surprises are in the nation-wide character of the exposure and the levels ofexposure experienced by citizens living so far from the Test Site.

While the passage of time continues to reduce the threat level, it is important torealize that the threat of exposure from these tests is still with us.

The half-life of Iodine-131 is only about 8 days, so that material that was nottaken up by individuals within several weeks of the tests is no longer of concern.

However, other fallout ingredients have much longer periods of radioactivity. Forexample, Strontium-90 and Cesium-137 have half-lives of about 30 years. These arealso taken up by the body and exhibit radioactive emissions very similar to Iodine-131.

Consequently, the Iodine-131 study, which is continuing, should continue. But thisstudy addresses only a part of the story. Other exposure threats and the resultingrisk to succeeding generations need to be considered.

The tools and methodologies developed for Iodine-131 exposure will provide muchof what is needed to consider other radioactive threats from this critical period inour nation’s pursuit of global peace and security.

I would be remiss if I did not point out the obvious: our citizens were neitherknowingly nor frivolously exposed to risk. Well-meaning scientists and civic and po-litical leaders assured themselves and their constituencies that there was negligiblerisk in these tests that were so important to our national security.

It was not until much later that the magnitude and duration of the risk becamemore and more evident.

We should learn from past mistakes.The mistake in this case was one of proceeding with terribly intrusive and risky

actions before enough was understood about all the uncertainties surrounding theactivity.

5

Underground testing could have been used from the outset. It was not until therisks became more evident that the time and expense of moving the tests under-ground was accommodated.

Well, we are in the process of once again trying to repeat this kind of mistake.Permanent disposal of spent nuclear fuel and high level radioactive waste is sub-

ject to even greater uncertainties than was the original atmospheric testing pro-gram.

Yet, some are making Herculean efforts to circumvent the absolutely crucial proc-ess of understanding the suitability of the proposed disposal site and methodology.

The amounts and intensity of radioactive materials that would be dumped in Ne-vada far exceed that associated with all of the nuclear weapons ever explodedanywhere * * * and there is no guarantee that this dangerous stuff would be iso-lated from the environment throughout its hazardous period of 10,000 years.

There is no national security crisis, nor is there any other kind of emergency thatwould warrant doing anything at all until the consequences of disposal actions arewell and confidently understood.

PREPARED STATEMENT OF SENATOR MURRAY

Senator MURRAY. I as well ask unanimous consent that my fullstatement be made part of the record.

Senator SPECTER. Senator Murray as well.[The statement follows:]

PREPARED STATEMENT OF SENATOR PATTY MURRAY

Good morning and welcome to all of our distinguished witnesses. I want to saya special hello and thanks to Tim Conner, Associate Director of the Energy ResearchFoundation of Spokane, Washington who will be testifying later. Tim is an activehealth and environmental researcher and was a founder of a public interest organi-zation that works on issues of nuclear weapons production and environmental res-toration. I hope I will have the opportunity to hear his testimony, but I am alsolooking forward to meeting with him personally later today. I appreciate all of yourwork, Tim.

I also want to thank the chairman and ranking member for holding this hearing.I share the concern of many constituents and people across the nation who havebeen horrified to learn of the radiation ‘‘experiments’’ on unknowing citizens per-petrated by our government. Of course, it was a different world in the 1940’s and1950’s and we were fighting a Cold War. The United States government made mis-takes in its haste, fear and ignorance.

But I cannot understand why the National Cancer Institute has allegedly with-held information now, in the 1990’s, after we had won the Cold War. It is reprehen-sible that our citizens were intentionally exposed to radioactivity and yet those whoknew remained silent—even in the face of evidence that said if we provided treat-ment and information early, we might alleviate suffering or prevent diseases.

In my home state of Washington, the Atomic Energy Commission conducted itsown tests and released radioactive iodine into the air from the Hanford NuclearReservation. Many people in central and eastern Washington were exposed. Despiteseveral major studies and research projects, we are still uncertain about which di-rection to take. The Pacific Northwest National Laboratory has compiled data on ra-dioactive releases and attempted to estimate the doses individuals received and pub-lished its results in the Hanford Environmental Dose Reconstruction study. TheCenters for Disease Control and Fred Hutchison Cancer Research Center are nowcompleting a long-term study on thyroid disease and are expected to finish thatenormous undertaking next year. The Agency for Toxic Substances and Disease Reg-istry has issued a medical monitoring plan, but has yet to locate a source of fundingto implement the plan. The Hanford Health Information Network is trying to locate,catalog and help educate potential victims. And these are only a few of the studiesand programs on-going to address the Hanford downwinders problems.

While we have a lot of activity surrounding these issues, we seem to be shorteron action. I believe the bottom line is the federal government must accept respon-sibility for harming its citizens. It must apologize. And it must help these peoplewith medical bills. These things are the very minimum we must do.

I look forward to working with this committee to develop a comprehensive policyto address the grievances of our citizens. This is a complex area, but one that hasbeen ignored for too long. Let’s figure out what our citizens need—and do it.

6

OPENING REMARKS OF SENATOR LARRY CRAIG

Senator CRAIG. Mr. Chairman.Senator SPECTER. Senator Craig.Senator CRAIG. Mr. Chairman, let me say only briefly that pre-

liminary releases of information in August suggest that four out ofthe five counties with the greatest concern are in my State ofIdaho, and as a result of that there is a sense of urgency for goodaccurate knowledge and understanding. I expressed frustrationthen and you will hear me expressing frustration throughout thishearing as the information unfolds.

PREPARED STATEMENT

Senator Harkin expresses his frustration about time and lengthof time. While the citizens of Idaho and this Senator do not wantnor will we rush to judgment, there is certainly a crying demandfor knowledge and understanding of what may or may not havehappened.

I will ask unanimous consent that my full statement be a partof the record, Mr. Chairman.

[The statement follows:]

PREPARED STATEMENT OF SENATOR LARRY CRAIG

Mr. Chairman, I am pleased to be here today and I thank you for holding thishearing on an important issue—one especially important to Idaho.

Today the National Cancer Institute releases its full report on iodine-131 falloutfrom above ground nuclear weapons tests. The report runs to some 100,000 pages,I am told. The summary alone is 1,000 pages.

Since it is being released just today, neither I nor my staff have yet had the op-portunity to review these results.

According to preliminary results released by the National Cancer Institute in Au-gust, however, the State of Idaho has four out of the five counties in the nation withthe highest radiation exposure to iodine-131 from the fallout of these weapons tests.

Individuals living in these five Idaho counties were estimated to have received acumulative average dose of 12 to 16 reds—with a 3 to 7 fold increase for childrenexposed between the ages of 3 months and 5 years.

These results are of great interest and concern to me and to my fellow Idahoans.They are eager and impatient to understand what these results mean.

Unfortunately, in reviewing today’s testimony and culling from the vast publichealth resources available, I am afraid this is a question we will not be able to an-swer today for Idaho citizens and other exposed populations.

I hope we will not spend all our time today trying to recreate the 14 year historyof what the National Cancer Institute did, or should have done, in producing thisstudy.

I hope we will not spend our time today attempting to put the decisions this Na-tion made at the height of the Cold War under the microscope of our modern think-ing.

What I do believe to be our charge here is to assemble all the facts. This is whatmy constituents have asked of me.

Simply knowing what the fallout levels were—a figure such as ‘‘15 rads’’—doesnot provide Idahoans with the information they need about possible health con-sequences. Specifically, the question that needs to be answered is:

‘‘Do these levels of fallout result in an increased risk of thyroid cancer or othercomplications?’’

In reviewing the testimony of our witnesses, I know that some of them have al-ready reached their conclusions on the health effects of these exposures, but thereis a tremendous diversity of opinion on this.

A number of health organizations are openly skeptical of any link between iodine-131 fallout and increased thyroid cancer.

As an example, let me quote from the position statements of two national healthorganizations.

7

The American Association of Clinical Endocrinologists states the following: ‘‘Doz-ens of studies involving even much larger doses of iodine-131 given to adults andchildren have shown no correlation between iodine-131 and thyroid cancer. * * *Over the past fifty years, hundreds of thousands of patients have received iodine-131 for medical purposes, and there is no increase of thyroid cancer in these pa-tients.’’

The American Thyroid Association states: ‘‘Radioactive iodine has been used formore than 50 years in almost 10 million individuals as part of routine thyroid func-tion tests * * * in amounts far greater than that delivered by the fallout and care-ful long term follow-up studies of these individuals have not shown any evidenceof excess thyroid cancer attributable to radiation exposure.’’

Perhaps the strongly conflicting opinions on this issue suggest the need for fur-ther and more conclusive study.

As tragic as the events at Chernobyl and the nuclear contamination in the FormerSoviet Union may be, the study of these exposed populations may be able to addto our understanding about the health effects of low levels of radiation exposure.

I understand that cooperative research in these areas is already ongoing. I en-courage these efforts.

When we have completed more definitive work on this link between weapons fall-out and cancer incidents—at that time—I believe Congress should look at any need-ed remedies.

One avenue of remedy may be an expansion of programs already available todown wind exposed populations—or ‘‘downwinders,’’ such as the Radiation ExposureCompensation Act of 1990.

Another idea that may have merit is the use of a voluntary registry of individualswith thyroid health complications. It could be similar to registries developed forsome of the Department of Energy dose reconstruction studies.

Such a voluntary registry would allow those who want to participate in follow-up and long term medical monitoring to contribute to our very sparse data on lowradiation dose health effects.

I want to close by emphasizing that the most important thing right now is forthose individuals who may have been put at increased risk to be provided with thefacts and information they need to make informed decisions about their health, andany medical monitoring that may be required.

Along these lines, I would like to see our national health organizations and gov-ernment health institutes working together—and in cooperation with state andcounty health organizations—on a public education campaign about the early warn-ing signs of thyroid disease.

Such an education campaign would raise people’s awareness and, hopefully, moti-vate them to seek early medical intervention, if needed.

I am committed to seeing that populations exposed to this radioactive fallout getthe information they need on this issue, in a timely way. I think our hearing todayis a first step in this process.

ATMOSPHERIC TESTS

Senator REID. Mr. Chairman.Senator SPECTER. Senator Reid.Senator REID. I would only say that I am probably the only per-

son here that actually watched those atmospheric tests go off. Weused to get up in the morning early and watch them light up thedesert sky.

Senator SPECTER. Just one note on the question of governmentaldisclosure. That is a recurrent problem, of greater intensity nowthan ever. We’re fighting with gulf war syndrome, where the De-partment of Defense did not make facts available from a 1991 fall-out until 1996. We are still in the midst, after having extensivehearings, on Ruby Ridge; on Khobar Towers, on the terrorist at-tack; and on INS and IRS.

This is a very fundamental failing which we find in our Govern-ment today, which requires very intensive efforts.

8

Dr. Klausner, we welcome you here. You have been before thiscommittee many times. We thank you for your distinguished serv-ice, and the floor is yours.

SUMMARY STATEMENT OF DR. RICHARD KLAUSNER

Dr. KLAUSNER. Thank you very much, Senators.One of the dark legacies of the above-ground nuclear tests was

that 160 million Americans alive during that period were to vary-ing degrees and unbeknownst to them exposed to radioactive fall-out. On August 1st we released our study estimating exposures ofthyroid doses of I-131 received by the American people, and todaywe release the details behind those results.

This is a study of unprecedented magnitude, utilizing the limiteddata available for each of the 90-plus tests between 1952 and 1958responsible for 99 percent of the I-131 released into the atmos-phere. These data were coupled with detailed wind patterns, rain-fall patterns, grazing patterns of cows and goats, transfer patternsto milk, milk distribution and consumption patterns, and the re-sults were then analyzed for all 3,000-plus counties in the 48 con-tiguous States for 13 age groups for multiple milk consumptionpatterns. The results are now available for each test, each seriesof tests, and cumulatively.

Before I describe some of the results briefly, I must emphasizethat there are significant uncertainties in these numbers. Becausethere were so few direct measurements at the time, much of thestudy relies on the development of mathematical and statisticalmodels to estimate patterns and exposures.

The average cumulative dose to all Americans was 2 rads. Bycounty, the average cumulative exposure, as we heard, ranged upto 15 rads. But, importantly, the average cumulative exposures forchildren are between three and seven times those numbers, whilefor adults it is about one-third to one-half. Children who wereheavy milk drinkers in certain areas may have been exposed to 100rads or more.

A rad, or a radiation absorbed dose, is a physical measure of ra-dioactivity. For comparison, during the 1950’s diagnostic thyroidscans used medically gave up to 300 rads of I-131.

What do we know about radiation and thyroid cancer? Most ofwhat we know is from external radiation sources, whereas the fall-out was largely due to internal, ingested radiation. At external ex-posures of about 100 rads, there is about a seven to eightfold in-crease in the incidence of thyroid cancer. This is only seen for ex-posed children, primarily those exposed under age five.

While it is virtually certain that internal exposure of I-131 canpredispose to thyroid cancer, there is much we do not know. We donot know the dose-response relationship. We do not know if the po-tency is the same as external radiation. If it is, we have estimatedthat these tests may have resulted in as many as 75,000 additionalcases of thyroid cancer to the children alive at that time through-out the course of their lives, about a 20-percent increase from theexpected number of thyroid cancers.

Over this time, the NCI has funded several studies attemptingto get at this issue of the relationship between I-131 and thyroidcancer. A large study of 35,000 individuals in Sweden exposed to

9

about 100 rads on average of I-131 failed to show a statistically sig-nificant increase in thyroid cancer.

More directly pertinent was an NCI-funded study published in1993 following a cohort of nearly 2,500 children in Utah, Nevada,and Arizona who had been exposed to fallout and were examinedin the sixties and again in the 1980’s. In this study there was apositive association between I-131 exposure and about a 3- to 31⁄2-fold increased risk of thyroid cancer. As the authors of the studypointed out, the small number of cancers observed limited the cer-tainty of the exact association.

Currently the NCI is engaged in an important series of studiesin Belarus and the Ukraine and following tens of thousands of chil-dren exposed to fallout doses upwards of thousands of rads, in radi-ation released during the Chernobyl nuclear accident. We believethat this study will provide the best single opportunity for estab-lishing human dose-risk relations as a function of age for thyroidcancer.

What about this study, the speed, its oversight, and the open-ness? The length of this study as far as I can tell in reviewing thiswas overwhelmingly a reflection of its complexity, as well as theprocess of review and evaluation. It was from its beginning over-seen by an expert advisory panel that guided its design andprogress through open public meetings.

Three interim reports to Congress were prepared by NCI, in1984, 1986, and 1991. Progress and results were presented at pub-lic meetings of the NCI Board of Scientific Counselors. It was re-ported each year in the annual reports. Multiple papers were pre-sented at public scientific meetings in 1987–90, 1994–95, and pub-lications about the study resulted from these presentations, includ-ing the extent and quantitation of the average overall exposure andthe level of increased exposure to children.

There is always a tension between our desire to disseminate andpublicize the results of studies and the need to ensure the integrityand quality of that information through the scientific peer reviewprocess. That said, I believe in this case that a more clear, morerapid, and more aggressive plan for dissemination of the results tothe public was called for.

Since I became aware of the study, over the past 6 to 8 monthswe have moved quickly to release the study in its entirety, all100,000 pages, in a form that would be accessible, understandable,and useable. This plan is described in detail in my written state-ment. But a unique feature I want to point out is that the entirereport and supporting data are totally accessible as of todaythrough the Internet, an approach that was not even available 3years ago.

Despite the tremendous interest in this study, let me emphasize,as actually Senator Harkin has talked about in the newspapers,that the results confirm widely discussed and published ranges andextent of fallout exposure which have been the subject of an enor-mous amount of attention, including by the Congress, since the1950’s. This study provides, we believe, both important new meth-odologies and much more detailed exposure information than hasbeen previously available.

10

But the results ought not to be characterized as unexpected. Thisparticular study was not designed to directly address the healthconsequences of these exposures. Estimates of additional cases ofthyroid cancer, as I said, that might have arisen have been made,but again are subject to uncertainty.

Preliminary analyses, which I can show you later, of cancer inci-dence and mortality rates across age groups have been done, andwe have so far been not able to discern any obvious correlationwith areas of I-131 exposure. Let me emphasize, however, that thatdoes not rule out the likeliness that individuals exposed in the1950’s were placed at increased risk of thyroid cancer.

For now, the NCI agrees with the recommendation of the Amer-ican Thyroid Association that individuals concerned about theirrisk should consult their physicians for a manual thyroid exam.

While I have emphasized the uncertainties that surround thehealth consequences of I-131 exposure, such potential consequencesshould not be trivialized. HHS has requested that the Institute ofMedicine rapidly examine this study, how it was done, its validity,and other available information and independently report on itspublic health and medical implications.

PREPARED STATEMENT

The NCI appreciates the interest and concern that you and thepublic have expressed that high quality information be providedabout nuclear fallout. This is especially true in the context of thelegacy of the cold war, in which such information was too often notprovided or even hidden. We hope this study will contribute to ourknowledge about the release and distribution of I-131 and how in-dividual exposures can be assessed.

I thank you for this opportunity to describe the study and hope-fully clarify its limitations, and I’m pleased to answer any ques-tions.

Senator SPECTER. Thank you very much, Dr. Klausner.[The statement follows:]

PREPARED STATEMENT OF RICHARD D. KLAUSNER, M.D.

Good morning Senator Specter, Senator Harkin, and Members of the Subcommit-tee. I am Richard Klausner, Director of the National Cancer Institute (NCI), andtoday I am presenting to you, for the first time, the completed NCI report estimat-ing thyroid doses of Iodine-131 (I-131) received by Americans as a result of atmos-pheric nuclear bomb tests conducted at the Nevada Test Site. This study was con-ducted in response to legislation enacted by the 97th Congress of the United States.

PUBLIC LAW

Public Law 97–414, in part, directed the Secretary of the Department of Healthand Human Services (DHHS) to conduct scientific research and prepare analysesnecessary to develop valid and credible methods to estimate the thyroid doses of I-131 that are received by individuals from nuclear bomb fallout, and to develop validand credible assessments of the exposure to I-131 that the American people receivedfrom the Nevada atmospheric nuclear bomb test. The magnitude, complexity anddifficulty of such research is without precedent and the fact that such a study wascompleted is testimony to the expertise and commitment of a large number of gov-ernment and non-government scientists, and particularly of two NCI researchers—Dr. Bruce Wachholz and Dr. Andre Bouville. The study was designed and carriedout with the help of an Advisory Committee with representation from the fields rel-evant to radiation science. This study was not designed to evaluate the health ef-fects of I-131 exposure, so such risk estimates are not part of this study.

11

I-131 RELEASE AND DEPOSITION

Ninety nuclear tests released almost 99 percent of the total I-131 entering the at-mosphere from the bomb tests conducted at the NTS. These 90 tests released about150 million curies of I-131, mainly in the years 1952, 1953, 1955, and 1957. Someradio-iodine was deposited everywhere in the U.S., with the highest deposits imme-diately downwind of the NTS. The lowest deposits were on the west coast, upwindof the NTS. In the eastern part of the country, most of the deposited I-131 was asso-ciated with rain, while in the more arid west, dry deposition (where particles settleon the ground) prevailed. Because I-131 has an 8-day half-life, exposure to the re-leased I-131 occurred primarily during the first two months following a test.

DOSE RECONSTRUCTION

A major challenge of this study was the attempt, three to four decades after theevents, to retrospectively assess the exposure of persons throughout the country. Formost tests, however, it was possible to estimate the amounts of radioactivity depos-ited on the ground in fallout from the measurements of radioactive particles col-lected on sticky surfaces (i.e., gummed film). These collection units were geographi-cally dispersed around the United States, and the collections were made systemati-cally as part of an environmental monitoring program. These original data were re-analyzed in order to estimate the I-131 component in the fallout. Beginning withsuch measurements, the study used mathematical modeling of these and other rel-evant measurable data to estimate the levels of thyroid exposure in approximately160 million Americans in the 48 contiguous states of the country during the testperiod. In the absence of environmental radiation measurements during some tests,meteorological dispersion models were developed to calculate the amount of falloutdeposits.

The assessments of thyroid exposure have two components: deposition of I-131and the exposure of persons. First, mathematical models were developed to estimatethe amount of I-131 deposited in each of 3,094 counties (and sub-counties mappedin a few areas) in the contiguous 48 States. This involved re-analysis of data frommonitoring stations in operation across the U.S. during the testing program and theuse of a meteorological model. This information, coupled with precipitation data foreach county during the time the fallout clouds were over the U.S., permitted esti-mates of I-131 deposition. The dispersion of the cloud was tracked at four differentaltitudes in the days after each test to determine distribution of radioactive clouds.This component of the study was carried out in cooperation with experts from theDepartment of Energy (DoE) and from the National Oceanic and Atmospheric Ad-ministration (NOAA).

Second, thyroid exposure to the U.S. population resulting from this fallout wasassessed. It is well known that consumption of milk from cows grazing on contami-nated pastures is the principal route by which I-131 is incorporated into human tis-sues, especially for children. Most of the exposure to environmental I-131 resultedfrom the consumption of this contaminated milk and, for some individuals, from theconsumption of fresh goats’ milk. This component of the study, which was carriedout with the help of experts from the U.S. Department of Agriculture (USDA), in-volved the compilation of extensive and detailed information regarding pasture con-sumption and grazing patterns, the production of milk by cows, and milk distribu-tion and consumption patterns throughout the country. These data were used inmathematical models to estimate the transfer of I-131 from deposition on theground to the intake by humans of I-131 resulting from the consumption of contami-nated cows’ milk of various origins. In addition, other exposure pathways such asthe consumption of contaminated goats’ milk, eggs, leafy vegetables, and cottagecheese were considered as well as the inhalation of contaminated air.

Finally, thyroid dose was estimated on the basis of the exposures that were as-sessed for each nuclear test and each county of the contiguous United States. Thy-roid doses from intake of I-131 vary substantially as a function of age and dependmainly on the size of an individual’s thyroid gland and on the amount of fresh cows’milk an individual consumed. For that reason, thyroid doses were estimated for 13age categories, including four in-utero ages, four for infants under one year of age,four for children under age 20, and adults. The thyroid doses to adults were esti-mated separately for males and for females. Also, because the origins of milk andthe level of consumption vary substantially from one individual to another, thyroiddoses have been estimated for people drinking average amounts of fresh cows’ milkwith average I-131 contamination levels from commercial sources; for people drink-ing large amounts of cows’ milk with above-average I-131 contamination levels fromcommercial sources; for people drinking milk from backyard cows; and for peopledrinking no cows’ milk but consuming other foodstuffs contaminated with I-131.

12

The calculation of these thyroid doses resulted in the production of about 100,000pages of data and analyses that show—by county, for each weapons test, each seriesof tests, and the entire testing period—average levels of predicted exposure for the13 age groups and for both genders, and for four milk consumption patterns. In ad-dition, detailed maps have been prepared, showing the deposition pattern of I-131on the ground and the average thyroid doses for the population of each county ofthe contiguous United States after each weapons test and series of tests. The overallaverage thyroid dose to the approximately 160 million people in the country duringthe 1950’s is estimated to have been about 2 rad. ‘‘Rad’’ means ‘‘radiation absorbeddose.’’ It is a physical unit of energy deposition. To put this amount of exposure intoperspective, routine medical use of x-rays during the 1940’s and 1950’s exposed chil-dren to anywhere from 5 to several hundred rad, and all persons receive doses fromnatural background radiation of about 0.1 rad per year.

Because the study relied on a limited number of measurements and was basedessentially on mathematical models, the uncertainties associated with the thyroiddose estimates are fairly large, usually a factor of three or more for averages per-taining to population groups; for individuals the uncertainties might be greater.However, a comparison of the results obtained in this study with those derived fromthe few I-131 measurements that were carried out in the 1950s, either in the urineor in the thyroids of people, or in cattle thyroids, show a reasonably good agreement.

PUBLIC AWARENESS

It is important to note the context in which this study was carried out. What wasknown publicly about fallout? During the late 1950’s and early 1960’s a series ofCongressional hearings were held and the published scientific literature was intro-duced into the public record. The preliminary results of the NCI study are remark-ably consistent with these early reports. For example, the range of estimated I-131exposure for children had previously been identified in the 1960’s ranging from 4to 120 rad; the NCI study places ranges between zero and 100 rad. The results ob-tained in this study are also consistent with those obtained by the DOE and theUniversity of Utah for populations living in states close to the Nevada Test Site.

As the preliminary findings of the NCI study took form in the early 1990’s, NCIstaff made a decision to prepare the data and formulae to be useful, accessible, anduser friendly. An interactive format, now available on the World Wide Web, allowsan individual to estimate his or her own exposure. By designating a state and coun-ty, and date of birth, users will receive a table of the estimated doses to the thyroidafter each nuclear test. Dosages are also calculated for four different milk-drinkingscenarios.

INTERIM REPORTS

During the time period of data collection, calculation, and analysis, the NCI draft-ed status reports in 1984, 1986, and 1991 for transmittal to the Congress by theSecretary, HHS. The methodologies used in the study have been presented at sci-entific meetings since the project’s inception in 1983. Meetings of the I-131 AdvisoryCommittee, which was chartered in 1984 with experts in all relevant fields ofscience to assist NCI staff in carrying out this study, were open to the public. Itserved until 1993 as a place where presentations and discussions of the latest find-ings of the study and more broadly in the scientific arena could be aired. Updateswere presented frequently to the NCI’s Board of Scientific Counselors and in openmeetings. Papers about the study have been presented at national and internationalscientific meetings since 1987. Since 1990, preliminary results have been publishedin the scientific literature.

THYROID CANCER AND RADIOACTIVITY

Thyroid cancer is uncommon, accounting for just one percent of all cancers in thiscountry. Each year about 16,000 cases are diagnosed in the U.S., with an estimated1,230 deaths. Thyroid cancer is very curable, with the five-year survival rate at 95percent. This type of cancer occurs more often in women than in men, and is seenat ages as young as 5. In men, incidence rises gradually with increasing age, level-ing off after about age 70, whereas in women the increase is steeper, leveling offafter age 30 or 35. Between 5 and 10 percent of cases eventually result in death,usually after age 50 and usually attributable to the relatively rare anaplastic andmedullary forms of the disease.

Scientists do not know what causes most cases of thyroid cancer. One known riskfactor is exposure to external radiation during childhood. Commonly, during the1940’s and 1950’s, children received x-ray treatments to the head and neck for non-

13

cancerous conditions such as enlarged tonsils, enlarged thymus gland, acne, andringworm of the scalp, and as a result these individuals have a higher-than-averagerisk of developing thyroid cancer many years later. A compilation of multiple studieshas demonstrated that exposure during childhood to 100 rads of external radiationresults in a 7–8 fold increased risk of thyroid cancer. The vast majority of risk isseen for children who are exposed below the age of 10.

While it is very likely that exposure to I-131 also increases the risk of thyroid can-cer, there is considerable uncertainty as to the relative carcinogenicity of I-131 fall-out exposure compared to external radiation. Throughout the course of the falloutstudy being released today, the NCI engaged in and funded studies attempting toevaluate the risk of thyroid cancer from I-131, in order to fulfill the third componentof the legislation, which was to determine the risk of thyroid cancer associated withI-131 exposure.

Thus far, studies of exposure to I-131 for medical purposes or from fallout in areasdownwind from the site of atomic bomb tests during the 1950’s have not producedconclusive evidence that such exposure to I-131 is linked to cancer. In 1992, theUniversity of Utah reported a statistically significant dose-response relationship be-tween exposure to radioiodines and occurrence of thyroid neoplasms (combined be-nign and cancerous tumors) in a group of nearly 2,500 children in Utah, Nevadaand Arizona who had been examined in the 1960’s and again in the 1980’s. How-ever, while the correlation between the I-131 radiation dose and thyroid cancersalone was suggestive, it was not statistically significant and therefore could havebeen due to chance.

The relationship between I-131 exposure and thyroid cancer continues to be stud-ied. In 1985, NCI collaborated with Swedish scientists on a study of diagnostic I-131 received by 35,000 patients who received an average dose of 100 rad to the thy-roid. At this mean dose an excess risk of thyroid cancer was seen only among per-sons referred for examination because a thyroid tumor was suspected. The study in-cluded 2,408 persons exposed before age 20, and 314 children aged 10 and under.Among persons between 15–19 years of age, two cases of thyroid cancer were ob-served compared to 1.5 cases expected. No cases were seen in children under age15.

It is perhaps too early to know, but it seems likely from preliminary informationthat thyroid cancer increased in those populations of Belarus, Ukraine, and Russiamost affected by the Chernobyl accident, and that I-131 exposure is the probablecause. Assuming the eventual results are positive, the unresolved question will behow the risk from I-131 exposure compares to the risk associated with similar dosesfrom x-rays. The Chernobyl nuclear accident provides a tragic opportunity to obtainvaluable information needed to further develop these risk estimates. NCI staff rec-ognized the value of this opportunity to address that component of Public Law 97–414 that instructs the government to carry out research to make assessments of therisk of thyroid cancer from I-131. Our studies, supported jointly by the Departmentof Energy and the Nuclear Regulatory Commission, include about 15,000 childrenin Belarus and 30,000–40,000 in Ukraine, a number of whom received doses in ex-cess of 1,000 rad to the thyroid. The I-131 Advisory Committee as well as the NCIbelieved that it was in the interests of the U.S., as well as the world community,to invest the time and effort needed over the past several years to accomplish thecomplex negotiations required to undertake cooperative studies of thyroid diseasewith scientists in Belarus and Ukraine.

NCI is currently analyzing thyroid cancer incidence in our SEER (Surveillance,Epidemiology and End Results) Program and in nationwide mortality data. Prelimi-nary analyses of these data across age groups have been done and we do not discernany obvious correlation with areas of high I-131 exposure. However, these analysesdo not rule out the possibility that thyroid cancer risk has been elevated in exposedindividuals and we are continuing to evaluate these data to look for more com-plicated patterns. We also are investigating the possibilities of conducting otherstudies, and expect that further discussions along these lines will be undertaken bythe Institute of Medicine.

WHAT’S NEXT?

Communication planSince I became aware of this study last Spring, we moved as quickly as possible

to format and prepare the entire study for release in a form that was accessible andunderstandable. The goal of the NCI has been and continues to be to fully informthe public as to the results of research while adhering to quality control proceduresto assure that information released is of high scientific quality and credibility.

14

We have established an infrastructure to provide technical assistance to healthcare providers and health departments in interpreting the report (see Help Linebelow), and to respond to inquiries from patients and individuals exposed to radi-ation fallout, and to the media. We are working with the American Thyroid Associa-tion to provide interim education resources to physicians, patients and the public.We are helping state health departments interpret the report and respond to inquir-ies at the state and county level. We have announced through the media the avail-ability today of the full report. The Cancer Information Service (CIS) has interimguidance and background information for all target audiences about the incidence,mortality and survival rates for thyroid cancer, and statistical information abouttrends in mortality, incidence, and survival in high-exposure areas.Dissemination plan

NCI has announced today, through media channels, Congressional channels, andthrough state health departments:

—the availability of the I-131 report, including appendices and data, on the worldwide web. The information is available at the NCI web site (http://www.nci.nih.gov) and at its public, patient and media sub-page (http://rex.nci.nih.gov). At either site, click on ‘‘What’s New.’’

—the availability of a technical assistance helpline (1–800–273–7092) for healthofficers and health professionals. This telephone number, to be operational be-ginning October 1, is 1–800–273–7092.

—interim guidance with the American Thyroid Association for health profes-sionals on helping individuals concerned about fallout exposure.

—the availability of background information on thyroid cancer for members of thepublic and cancer patients from the Cancer Information Service at 1–800–4–CANCER (1–800–422–6237).

—that the study’s narrative report was express-mailed to state health depart-ments and other government agencies and select congressional members.

Help lineNCI has established a toll-free technical assistance helpline (1–800–273–7092) to

assist professionals in interpreting the report. We envision that support will be pro-vided to health professionals such as public health officials, researchers, radiationepidemiologists, advocacy and special interest groups, and physicians and otherhealth care providers. Voice mail is available for after-hours calls. Staff assistingwith answering calls will have sufficient educational background and knowledge toeffectively triage the calls and respond with credibility. We have also established aparallel system and procedures for responding to e-mail requests for technical as-sistance. Health officers and health professionals may send e-mail requests toCISOCC@nih.gov. Public and patient inquiries and e-mail will continue to be han-dled by the CIS. NCI staff will handle Congressional and press inquiries.Institute of Medicine

An NCI contract with the National Academy of Sciences-Institute of Medicine(IOM) went into effect September 30, 1997. The IOM will produce two substantivereports. The first, which is to be published in April 1998, will assess the soundnessof the I-131 study’s dose reconstruction, provide a preliminary assessment of thepublic health implications, and provide information to enable DHHS to educate andinform members of the public and the medical profession. The second report, to bepublished in June 1998, will develop recommendations for how we should addressthe public health implications (including intervention, surveillance, education andinformation strategies and clinical practice guidelines), and develop recommenda-tions for research strategies that could refine risk estimates and reduce uncertaintyof the effect of exposures.

There have been preliminary discussions within the Administration about the for-mation of a workgroup to look at broader issues. DHHS will convene a meeting be-fore the end of the year to begin the process.

Until the IOM completes its report, we are suggesting that concerned individualsconsult with their physician during their next visit. This recommendation is consist-ent with the position of the American Thyroid Association, which says that individ-uals who believe they may have been exposed to significant amounts of fallout andfeel they are at particular risk might wish to see their physician.Closing

The NCI appreciates the great interest and concern that you and the public havethat high quality and fully disclosed information be provided about nuclear fallout.This is especially true in the context of the legacy of the cold war in which suchinformation was too often not provided or hidden. We hope that this study will con-

15

tribute to our knowledge about the release and distribution of I-131 and how indi-vidual thyroid exposures can be assessed.

Thank you for this opportunity to describe this NCI study and to clarify its limita-tions. I would be pleased to respond to questions.

(17)

PANEL 1

NONDEPARTMENTAL WITNESSES

STATEMENT OF JOSEPH LYNN LYON, M.D., M.P.H., PROFESSOR, DE-PARTMENT OF FAMILY AND PREVENTIVE MEDICINE, UNIVER-SITY OF UTAH SCHOOL OF MEDICINE

Senator SPECTER. I think that our discussion may be facilitatedif we call our expert witnesses now: Dr. Lyon, Dr. Beyea, Mr. Con-nor, Dr. McGuire. Dr. Joseph Lyon is a professor of family medicineat the University of Utah and was the principal investigator of astudy in the 1980’s examining the health impact of atomic fallouton citizens of Utah.

Dr. Lyon, we welcome you here. The floor is yours, Dr. Lyon.Thank you for joining us.

Dr. LYON. Thank you very much, Senator Specter and ladies andgentlemen of the panel.

I want to perhaps rehearse again some of the history you havealready heard. Testing began 46 years ago this month in the Ne-vada test site. I counted at least 100 tests that were done above-ground, of which at least 25 distributed radiation well beyond thetest site, we now know, as far East as the east coast of the UnitedStates. The most heavily affected areas known at that time are thetwo southwestern-most counties of Utah, containing about 10,000people.

There was public concern expressed starting in the mid-fiftiesover the health effects, principally by scientists. This prompted twocongressional hearings, and the result of the second hearing in1959 prompted the U.S. Public Health Service to initiate a studyto look at two of the diseases, one of which we have talked abouttoday, thyroid cancer. The other was leukemia. The focus was onthese two southwestern Utah counties.

The studies, the initial studies, were carried out by Mr. Ed Weissof the Public Health Service. I think it is instructive for the patternthat has been set by this study to look at these. The leukemiastudy found about a threefold excess of cancers among childrenwho were under age 19 living in these two southwestern counties.That result was known by 1964.

The thyroid study, which Dr. Klausner has referred to becausewe carried out a second followup on that group, was severely lim-ited by the fact that there was no individual doses on anybody. Itfound nothing. Now, what happened at that point in time was thatthe thyroid study was published, highlighted, and used to reassurethe citizens of Utah of the adverse effects. The leukemia study wasburied in the files of HHS after a high level meeting at the WhiteHouse because of its impact. That study remained virtuallyunfollowed up and reassurances were offered to the citizens ofUtah when officials knew full well that there was a hint. It was

18

found exactly where they thought it would be and exactly the popu-lation.

It became instructive because that is generally how the FederalGovernment responds to the issues of citizens’ concern. That is, thenegative was strongly emphasized, the positive was suppressed orcovered up, and those who found the positive were frequently in-dicted. I do not know what this did to Weiss’ career. He never fol-lowed up the study, nor was there any effort to obtain anydosimetric information.

Senator SPECTER. Did you say he was indicted?Dr. LYON. I say I do not know what ever happened to the man,

but he never followed up on that study, and I think he was not per-mitted to.

We inadvertently stumbled on Weiss’ study and replicated itwithout knowing we were doing so, responding to newspaper ac-counts by a local newspaper in 1977 that there was an excess ofleukemia. It was based on the National Cancer Institute atlases. Iwas involved with the Utah Cancer Registry at the time. I felt thatthis was an issue that kept surfacing, that we ought to at leastlook at leukemia, but I felt that the probability, based on the thy-roid studies, was very low that anything would be found.

Much to our surprise, we found about a two and a half fold ex-cess of leukemias among children in the southern parts of theState. As I say, unknowingly we had replicated the study alreadydone by the U.S. Public Health Service and long since suppressed.

That finding, which was published in 1979, created intense con-troversy, as you can imagine. Efforts to follow up, that is obtainfunding, to try to obtain better dosimetry, to try to obtain largersamples, thrust us into a political situation that even the Presidentof the United States at that time was not able to, on his guarantee,to get us funding. It finally took the personal intervention of OrrinHatch, using a great deal of clout.

The funding came to us in three hunks of money: one-third fromNCI, two-thirds from DOE and DOD. That study, which ran forabout 8 years, was essentially heavily influenced by both of thoseDepartments.

There were several things that came out of that study from a sci-entific standpoint. First, we confirmed the leukemia findings forthe southern portions of the State and placed dosimetry estimateson them. We also confirmed that, as Dr. Klausner has mentioned,there was about a three and a half fold excess of thyroid neoplasmsin these school kids that had been previously examined in the mid-sixties.

There were enough scientific findings to suggest that there wereadverse health effects. What happened personally and at a politicallevel was much different. Let me give you a couple of examples.

We found excess leukemias that extended into northern Utah,where there are a much larger number of people, where you havegot about 80 percent of our population. The site visit committeewith the Department of Energy and Department of Defense rep-resentatives very busily revised all the dose estimates downwardfor northern Utah after they saw the study findings. Now, this isgenerally something that graduate school students are failed out of

19

graduate school for, but the Federal Government was able to getaway with it. So the finding was confined to southern Utah.

When the study was slated for publication in the Journal of theAmerican Medical Association, someone at NCI or DOD or DOEleaked the results to the local newspaper with the statement thefindings were inconclusive and did not support the earlier associa-tions. We were embargoed by the journal and could not respond tothose criticisms. My colleagues still to this day who didn’t read thestudy console me for the fact that I have a negative study. I haveto ask them to go and read the findings and suggest that a seven-fold excess of leukemia is not a negative study.

The third thing that Dr. Klausner may not have been aware ofis that the small numbers of the thyroid cohort study that so con-cerned us also, prompted us to submit a grant to the National Can-cer Institute or to the NIH for followup. It was approved and fund-ed. Someone at the NCI intervened with the Board of ScientificCounselors to make sure that the funding was not available. Wewere thrown around between various agencies, with the grant fi-nally assigned to the National Institute of Digestive and KidneyDisease—a very strange place.

We were never given the ability to respond to any of the criti-cisms which were made of that application after it had been ap-proved and funded.

Senator HARKIN. What year was that?Dr. LYON. That happened in 1989. We have been trying to fund

that study for followup. The study needs more—we know the peo-ple, we know their doses. We have not been able to obtain any Fed-eral funding to follow these people.

I think the handling of the studies is indicative, or at least itseems to me indicative, of some of the behavior we have seen withthis NCI study: essentially, accentuate the negative; if the negativelooks too threatening, do not publish it.

I guess in conclusion I would simply say that, given the long andrather unfortunate history of the behavior on the part of manyFederal officials, I think studies of this nature need to be assignedto an agency that has a strong public health interest and that hassubstantial public involvement. There was no public involvement inany of the studies we were involved in. We had attempted to geta public group set up and basically the advisory committee told usto not do so. I think it needs to be placed in agencies.

In conclusion, I would have to say that if the NCI were to callme tomorrow and say, Dr. Lyon, we will fund your thyroid study,I would say: If it is at the NCI under the current administration,I would really prefer to pursue my career in other areas.

Senator HARKIN. Prefer what?

PREPARED STATEMENT

Dr. LYON. I would prefer to pursue research in other areas, sim-ply because I do not think that the current administration is par-ticularly interested. And we have already had ample—I have al-ready experienced ample problems with trying to carry out re-search on this topic with a less than friendly Federal Government,particularly within the scientific establishment.

[The statement follows:]

20

PREPARED STATEMENT OF JOSEPH L. LYON, M.D., M.P.H.

Good morning, I am Joseph L. Lyon. I am a full professor in the Department ofFamily and Preventive Medicine, University of Utah School of Medicine, Salt LakeCity, Utah. I received my M.D. degree from the University of Utah, and a Masterof Public Health degree from Harvard University. My professional research interestsare in the causes of diseases in human populations, and I am a chronic disease epi-demiologist. I am appearing before this committee to testify on the health effectsthat arose from above ground nuclear testing at the Nevada Test Site (NTS) be-tween 1951–1958 and its relationship to the recently released report by the NCI ofextensive contamination of large areas of the United States by radioactive iodinegenerated by these tests. I shall comment on the activities of the U.S. Governmentalso through its’ various agencies to inform the public about the health risks associ-ated with fallout from above ground nuclear testing at the NTS. This is the fourthtime I have appeared before committees of the United States Senate investigatingthe cancers believed to be caused by U.S. above ground nuclear weapons testing.

Between 1951–1958 the U.S. Atomic Energy Commission detonated over 100 nu-clear weapons at its test site in the Nevada desert. At least 25 of these detonationsproduced measurable radioactive fallout in populated areas of Utah and states fur-ther north and east. One test in particular, Shot Harry, detonated about 5:15 a.m.on the morning of May 19, 1953, accounted for about 80 percent of the total radi-ation deposited in southwestern Utah.

There were concerns among the public and scientists about the increased risk ofcancer to the Utah population from radioactive fallout, but these were generally ig-nored. These concerns led to a Congressional hearing in 1959. There was no evi-dence of any health problems, but no studies of the people most heavily exposed hadbeen done. However, because of potential health concerns, the U.S. Government de-cided to move all further nuclear testing underground.History of a cover-up

In 1960 the Federal Government, responding to the health concerns raised by the1959 Congressional hearings, began two studies in Utah of cancers associated withradioactive fallout. These studies were limited to the southwestern most counties inUtah, Washington, and Iron Counties, and an adjacent county in western Nevada.The diseases chosen for study were leukemia and thyroid neoplasms. It was alreadywell established that exposure to gamma radiation could cause an increase in leuke-mia mortality, and there was concern that the radioactive iodine generated by a nu-clear detonation would enter the food chain via milk and expose the thyroid gland.

The U.S. Public Health Service investigated leukemia deaths between 1950–1964in the two Utah counties closest to the NTS and found a 3.29 fold excess amongthose under age 19, and a 1.5 increased risk of leukemia for citizens of all ages.No effort was made by the principal investigator, Mr. Edward Weiss of the U.S.Public Health Service, to link the extensive data gathered by the AEC on radiationdoses received by citizens of the two Utah counties to the location of the individualchildren who died to determine if the excess leukemia deaths might be related toradioactive exposure from the NTS. This would have been the next step to deter-mine if radioactive fallout was the cause of the excess leukemia in southwesternUtah, but this was not done nor was it even discussed in the written report of thestudy.

The study findings were written up in the form of a scientific paper by Weiss andgiven to his superiors for their approval before submission to a scientific journal.The manuscript was circulated within the U.S. Public Health Service and the Atom-ic Energy Commission. It was severely criticized as to the study size and choice ofcontrol group. There was some division of opinion among the public health officialswho wanted the findings published and atomic energy officials who did not. Thiswas resolved at a 1965 meeting at the White House presided over by the President’sScientific Advisor. The decision was made not to publish the paper because thestudy was based on a small number of deaths, and the officials of the Atomic EnergyCommission did not wish to unduly alarm the public with alarming but inconclusivefindings. Implicit in this decision to stop publication of the first evidence of an asso-ciation between fallout from above ground weapons testing and leukemia was theimpact such a finding might have on the U.S. Government’s continued nuclearweapons testing program.

The written reasons given for blocking publication of Weiss’s leukemia study wereproblems in study design and interpretation of results. Rather than trying to correctthese problems by adding more years of observation, obtaining a local control group,and linking radiation exposure by individual deaths, nothing more was done. Thedecision to do nothing to follow up after finding excess leukemia deaths among

21

young people living in the two Utah counties that were known to have been mostheavily exposed to NTS was even more reprehensible than the decision to suppressthe original paper. It meant that every Government official thereafter who offeredreassurances to the people of Utah that there had been no cancers caused by radi-ation was knowingly or unknowingly lying to the public.

An interesting sidelight to this episode did occur. The U.S. Centers for DiseaseControl was contacted by someone in the Public Health Service and asked to inves-tigate the excess leukemia deaths in southwestern Utah to determine if they mighthave been caused by an infectious agent. The CDC investigators were never in-formed that the children who died of leukemia had received substantial exposureto radiation from the NTS, and so no information was obtained during the CDC in-vestigation about the radiation exposure the dead children had. Not surprisingly nocause for the excess leukemia deaths was found. The hypothesis that an unknowninfectious agent can cause leukemia clusters, an idea popular in the 1960’s, has notbeen substantiated by further research, but exposing the children of a county to 5∂rads of gamma radiation will cause extra leukemia deaths to appear within a fewyears.

The second study of the carcinogenic effects of radioactive fallout was conductedby the U.S. Public Health Service to determine if the radioactive fallout had in-creased thyroid cancer rates among children in southwestern Utah. About 3,000school children living in the fallout contaminated areas of Western Nevada andsouthwestern Utah (White Pine County, Nevada and Washington County, Utah),and a control group of 2,000 children living in southern Arizona were identified andexamined for thyroid neoplasms.

This study was well designed and conducted. But despite suggestions by internaland outside consultants, no information about the source and amounts of fresh cow’smilk that each child had drunk during above ground testing at the NTS, the prin-ciple route of exposure to the thyroid gland, was obtained. This made it impossibleto assign a radiation dose to any of the children. An error of this magnitude in anepidemiologic study is simply not possible by chance. It is comparable to conductinga study of lung cancer without asking about cigarette smoking. Given this astonish-ing error, the study found no excess cancers of the thyroid gland. Thereafter, thenegative findings from this study were often cited to reassure the public that nocancers had resulted from above ground nuclear testing.

Both of these scientific studies commissioned by the U.S. Government to deter-mine if there were cancers associated with radioactive fallout from the NTS failedto meet minimal criteria for an epidemiolgic study, i.e., measure the exposure anddetermine if it’s related to a disease, by failing to measure exposure. Despite thisserious flaw, one of the studies found evidence that weapons testing fallout hadcaused excess leukemia deaths in Utah. This politically explosive finding was dealtwith by a cover-up, while the study that found no effect was publicized to reassurethe citizens of Utah that there were no cancers caused by fallout from the NevadaTest Site.

The basic pattern of how to deal with any scientific study that might suggest thatNTS fallout had caused cancer was determined for future generations by Federalbureaucrats through their handling of these two studies. The principles were as fol-lows: suppress any data that suggests a positive association between exposure andsubsequent cancer and mask your motives by stating that you do not want to un-duly alarm the people who were exposed. Cite only studies that found no associationto reassure people that their health concerns are groundless. And finally, do every-thing possible to make sure that no further scientific studies will be done that mightcontradict your position.

In February 1979, responding to a newspaper article that reported an excess ofleukemia deaths in southwestern Utah, three other colleagues and I published inthe New England Journal of Medicine a study of the association between childhoodleukemias and radioactive fallout generated from the detonation of nuclear weaponsat the Nevada Test Site. Children born in southern Utah between 1951–1958 experi-enced 2.44 more leukemia deaths compared to children born before and after aboveground bomb testing.

Unknowingly we had replicated and expanded the findings from the earlier, un-published study by the U.S. Public Health Service. The publication of this paper im-mediately made us the focus of an intense effort by the Federal Government to dis-prove our findings. University employed scientists complain that industry hire sci-entists to refute their findings when the findings might adversely impact the indus-try. Let me assure you that when the Federal Government is the polluter, it followsexactly the same strategy as any company. But the Federal Government has fargreater resources and power than are available to companies. For example, our

22

study was reanalyzed four times at substantially more cost than was spent on theoriginal study.

The publication of this study and the subsequent lawsuit filed by citizens livingin Washington County, Utah refocused attention on the carcinogenic effects thathave resulted from the fallout clouds generated by above ground testing at the Ne-vada Test Site. The Department of Energy not only continued to deny that any can-cers had resulted from the testing, but also set out to determine the extent of con-tamination of Utah and the rest of the United States by the radioactive falloutclouds. Crude measurements of fallout had been made at widely dispersed monitor-ing stations across the U.S. but had never been summarized or analyzed. It was thesummarization and computerization of these records that provided the dose esti-mates for the study recently released by the NCI.Re-examining the effects of fallout on Utah 1982–91

The findings from our 1979 leukemia study prompted a re-examination of the po-tential adverse health effects that might have been caused by exposure of the citi-zens of southwestern Utah to radioactive fallout from the Nevada Test Site. My col-leagues and I at the University of Utah were funded in 1982 through the NationalCancer Institute to determine if the excess leukemia deaths in southwestern Utahreported by us (and previously by Weiss of the U.S. Public Health Service) werereally related to radioactive fallout from the NTS. We were funded also to locatethe children previously examined for thyroid cancer and re-examine them. We wereto estimate a radiation dose to the thyroid gland for each study subject. Our fundingwas administered by the NCI, but two thirds came from the Departments of Energyand Defense, and these agencies, via regular sites visits, exerted substantial influ-ence on our study’s design, progress, and final interpretation of our results.

We published our findings for leukemia deaths in the Journal of the AmericanMedical Association in the July 31, 1990 issue (copy attached). We found a 7.82 foldexcess of leukemia deaths among those less than age 19 who were living in south-western Utah during the period of above ground nuclear testing.

The public impact of this article was diminished when some of the study findingswere leaked a week prior to its publication date to a newspaper reporter by someoneat NCI, DOE or DOD with whom we had shared the final manuscript of the article.The ‘‘spin’’ given by the leaker was that the study findings were inconclusive andcould not confirm the earlier studies by Weiss, and my colleagues, and I. Since ourarticle was embargoed by the journal until the day of publication, we could not re-spond to the media. We once again see the principles I mentioned above being ap-plied. When you can’t suppress findings of adverse effects from NTS fallout, publiclylabel the results as inconclusive, knowing full well that the investigators cannotcounter your ‘‘spin’’.

Using estimates of radiation exposure to 57 Utah communities provided by theU.S. Department of Energy and published in the journal, Science, in January 1984,we found a statistically significant excess of leukemia deaths in northern Utah also.But when these findings were shared with the Department of Energy representa-tives on our site visit committee, the published radiation exposure estimates wererevised We were informed that this revision was based on classified data. The radi-ation exposure to northern Utah from the NTS was decreased by assigning moreof it to exposure from Russian nuclear testing. This caused the association of leuke-mia with NTS fallout in northern Utah to become non-significant. We were deniedaccess to the classified data that was used to make this dose reassessment, and theDepartment of Energy never amended or retracted their original study of NTS radi-ation exposure published in Science.

We published our findings on thyroid disease and fallout in the November 3, 1993issue of the Journal of the American Medical Association (copy attached). We founda three fold excess of thyroid neoplasms among those with the heaviest exposuresto NTS generated radioactive iodines. The small number of neoplasms we found (18neoplasms of which 8 were carcinomas) means the findings must be interpretedwith some caution. We did not view the results as inconclusive because as theamount of radiation increased the number of neoplasms increased, and the numberof neoplasm produced per unit of radiation agrees with other studies of radiationand thyroid cancer.

Our finding, though based on a small number of new cases, was the first to sug-gest that normal individuals who were exposed as children to environmental con-tamination from radioactive iodines are at higher risk of developing thyroid neo-plasms. It cost us about $3 million to estimate a dose of radiation to the thyroidgland of these subjects. Most of the cost came from the need to identify and inter-view the mothers of the study subjects about their children’s milk drinking habits

23

from birth until age 18 and identifying and interviewing all dairy farmers and milkprocessors in southwestern Utah.

Because of the importance of our finding of an excess of thyroid neoplasms fromradioiodine released into the atmosphere from nuclear events to scientists studyingsimilar exposures, in October 1987 we submitted a grant application to the NationalInstitutes of Health to fund another cycle of examination of the former school chil-dren. This request was prompted by the small number of neoplasms we identifiedand the fact that a few more years of follow-up would resolve this problem. It wasprompted also by the fact that our subjects were just reaching the highest risk pe-riod for the development of thyroid cancer, age 40 and above. The application wasassigned to the National Institute of Environmental Health Sciences, reviewed, andreceived a fundable priority score. But the Board of Scientific Counselors at NIEHSdeclined to fund the application (see the letter dated February 28, 1989). We werenever given an opportunity to respond to the Board’s concerns were told the applica-tion had been reassigned to the National Institute of Diabetes, Digestive, and Kid-ney Diseases. We were told informally that our project officer for the 1982 NCIstudy, Dr. Bruce Wachholz, had requested that the Board take this action. WhileI cannot confirm Dr. Wachholz’s intervention, the Board members had detailed in-formation about the administration, methods, and findings of our study which werenot provided by us. We submitted the application again in 1991 to the NIH. Thepriority score was below the funding line, and so no further follow-up of this grouphas occurred despite repeated appeals to the Federal Government by me and theUtah Congressional delegation for funding.

Once again we see the principles I mentioned above being applied. When positivefindings occur, label the findings as inconclusive, and make sure that no furtherwork is done to strengthen the findings.Comments on the NCI iodine study

The release of the NCI report on radioactive iodine exposure of people outsideWashington County, Utah has once again raised scientific and political interest inthe findings of our thyroid study. Reassurances were offered to the public in thepress release put out by the NCI that the Utah thyroid study findings were ‘‘incon-clusive’’. The use of the term ‘‘inconclusive’’ to describe our thyroid study is dis-ingenuous. We found a three fold increased risk between childhood exposure to ra-dioactive iodine and subsequent thyroid neoplasms with a clear dose response rela-tionship. Certainly no researcher would consider exposing a group of children to ra-dioactive iodine based on such a finding. The only thing inconclusive about ourstudy was the small number of neoplasms detected, and we had proposed to remedythis weakness in 1988 by adding another five years of follow-up, but had been de-nied funding by the Federal Government.

I cannot understand why the findings from the NCI report were delayed for solong. There have been prior studies of the distribution of radioactive iodine fromabove ground weapons testing suggesting extensive contamination outside of Utah,and a colleague at the University of Utah, Dr. Victor Archer, reported an associationbetween NTS generated fallout and thyroid cancer in states remote from Utah inthe journal, Archives of Environmental Health, September/October 1987. The find-ings from the NCI thyroid study were being discussed among radiation researchersfive years ago, yet no one had the power to force the publication of the release untilthe press intervened this July.

After the NCI study completion in 1992 and as it was being edited, there wereno efforts by staff at the NCI to fund another cycle of thyroid examination of theUtah thyroid group, though they are unique in the world from a scientific stand-point: the only group of young children accidently exposed to radioactive iodine withcalculated radiation doses to their thyroid glands and data from two cycles of phys-ical examinations spanning 30 years. Instead, the findings were labeled as ‘‘incon-clusive’’. The findings were offered to reassure the public at the August 1, 1997 NCIpress conference. This followed the same pattern as the 1966–70 report on this samegroup when reassurance was provided to the citizens of Utah that there was noneed for concern over radioactive fallout.

I contrast handling the NCI study with recent reports of increased risk of pul-monary hypertension and heart valve damage from combination drug therapy forobesity commonly referred to as the phen/fen diet. Based on what would be labeledas ‘‘highly inconclusive’’ evidence, the manufacturer withdrew the drugs from themarket and took steps to set up medical surveillance of those who might have beenaffected. If phen/fen was being marketed by the Federal Government, what wouldhave been the Government’s action? Surely there is little question that ingestion ofradioactive iodine can damage and destroy the thyroid gland. Yet, to this day thereis no medical surveillance of the heavily exposed population of southwestern Utah.

24

And officials of the Federal Government have never met with these citizens to in-form them of their potential risk of thyroid cancer.

Finally, I believe that many of the problems I have detailed here concerning theFederal Government’s handling of the adverse health effects from radioactive falloutcould have been prevented had the Federal Agencies handling these problems beenwilling to appoint and work with committee-based citizens’ groups. These groupsneed to be involved at the initiation of any such study and be kept fully informedof the study’s progress and findings. Such has not been the case in any of the stud-ies of radiation carried out by the U.S. Public Health Service in Utah between 1961–70 and the NCI funded study carried out between 1982–91.Conclusions

The adverse health effects associated with the release of radioactive chemicalsfrom the NTS have been a cause of public concern for at least 40 years, promptingat least six previous Congressional hearings. The responsible Federal agencies haveconsistently responded to the public’s concern with evasion, deceit, and cover-upgarbed in the cloak of scientific objectivity. They have expressed a desire to obtainthe truth so that wise decisions could be made, while all the time trying to suppressor stop any scientific study that might confirm the public’s fears. When these tacticsfailed, the Federal officials labeled any study that suggested cancer or leukemiamight be associated with fallout as ‘‘inconclusive’’. Much of this behavior was justi-fied by these officials the grounds of national security considerations, but those con-siderations surely evaporated by 1991.

I was appalled to find that employees of one of the premier research institutionsin the world, the National Cancer Institute, in August 1997, were using the sametactics that have been used for the last forty years by officials from other FederalAgencies. Even more upsetting to me was that these tactics had been used to obfus-cate their own research findings of potential excess risk of thyroid cancer for manycitizens of the U.S. Do these scientists not believe their own research? I was alsoupset and angry that our study of thyroid disease in Utah was being used to reas-sure people that the association between exposure to fallout generated radioactiveiodine and thyroid cancer was ‘‘inconclusive’’. I had hoped that by 1997, employeesof the Federal Government involved with the important public health issues of ra-dioactive contamination of U.S. citizens by the actions of the U.S. Government hadreached a point where candor and honesty were foundation principles in dealingwith the public. This was not the case at the NCI in its handling and the recentradioactive iodine study and it saddens me.

The credibility of the Department of Energy has been so severely compromised bytheir handling of the adverse health effects of radioactive materials that in 1992,all health related research with the DOE was transferred to the Centers for DiseaseControl and Prevention. I am a member of the Secretary of Health and HumanServices Advisory Committee for Energy Related Research that has monitored thistransfer. The attitude and behavior of the Federal employees within the CDCP whoare taking over these radiation related research programs is in stark contrast tothat exhibited by those at the NCI. The CDC insists on citizen and/or worker in-volvement from the outset in every study. For example, in the study of thyroid can-cer in the citizens around the Hanford reactor, the Federal project officer has scru-pulously avoided knowing any of the study findings so as not to bias his administra-tive actions. Based on my observations of operating procedures and scientific integ-rity of the radiation epidemiology branch of the CDCP, I would recommend that allresearch within the Federal Government that involves the effects of radioactive fall-out on human populations be placed under the control of the U.S. Centers for Dis-ease Control and Prevention. I would not be willing to accept a grant to conductanother round of thyroid examinations on our Utah study group if the administra-tion of the funds was handled by the current radiation staff at the NCI.

[From the Journal of the American Medical Association, Nov. 3, 1993, vol. 270, pages 2076–2082]

A COHORT STUDY OF THYROID DISEASE IN RELATION TO FALLOUT FROM NUCLEARWEAPONS TESTING

(Richard A. Kerber, Ph.D.; John E. Till, Ph.D.; Steven L. Simon, Ph.D.; Joseph L. Lyon, M.D., M.P.H.; DuncanC. Thomas, Ph.D.; Susan Preston-Martin, Ph.D.; Marvin L. Rallison, M.D.; Ray D. Lloyd, Ph.D.; Walter Ste-vens, Ph.D.)

Objective.—To estimate individual radiation doses and current thyroid disease sta-tus for a previously identified cohort of 4,818 schoolchildren potentially exposed tofallout from detonations of nuclear devices at the Nevada Test Site between 1951and 1958.

25

Design.—Cohort analytic study.Setting.—Communities in southwestern Utah, southeastern Nevada, and south-

eastern Arizona.Participants.—Individuals who were still residing in the three-state area (n=3122)

were reexamined in 1985 and 1986, and information on the subjects’ and theirmothers’ milk and vegetable consumption during the fallout period was obtained bytelephone interview (n=3545). After exclusions to eliminate missing data and con-founding factors, 2,473 subjects were available for analysis.

Main outcome measures.—Individual radiation doses to the thyroid were esti-mated by combining consumption data with radionuclide deposition rates providedby the U.S. Department of Energy and a survey of milk producers. Relative riskmodels adjusted for age, sex, and state were fitted using maximum likelihood to pe-riod prevalence data for thyroid carcinomas, neoplasms, and nodules.

Results.—Doses ranged from 0 mGy to 4600 mGy, and averaged 170 mGy inUtah. There was a statistically significant excess of thyroid neoplasms (benign andmalignant; n=19), with an increase in excess relative risk of 0.7 percent permilligray. A relative risk for thyroid neoplasms of 3.4 was observed among 169 sub-jects exposed to doses greater than 400 mGy. Positive but nonsignificant dose-re-sponse slopes were found for carcinomas and nodules.

Conclusions.—Exposure to Nevada Test Site—generated radioiodines was associ-ated with an excess of thyroid neoplasms. The conclusions are limited by the smallnumber of exposed individuals and the low incidence of thyroid neoplasms.

[From the Journal of the American Medical Association, Aug. 1, 1990, vol. 264, pages 585–591]

LEUKEMIA IN UTAH AND RADIOACTIVE FALLOUT FROM THE NEVADA TEST SITE

A CASE-CONTROL STUDY

(Walter Stevens,. Ph.D.; Duncan C. Thomas. Ph.D.; Joseph L. Lyon. M.D. M.P.H.; John E. Till, Ph.D.; RichardA. Kerber, Ph.D.; Steven L. Simon. Ph.D.; Ray D. Lloyd, Ph.D.; Naima Abd Elghany, M.D. Ph.D.; Susan Pres-ton-Martin, Ph.D.)

Previous studies reported an association between leukemia rates and amounts offallout in southwestern Utah from nuclear tests (1952 to 1958), but individual radi-ation exposures were unavailable. Therefore, a case-control study with 1,177 individ-uals who died of leukemia and 5,330 other deaths (controls) was conducted usingestimates of dose to bone marrow computed from fallout deposition rates and sub-jects’ residence locations. A weak association between bone marrow dose and alltypes of leukemia, all ages, and all time periods after exposure was found. Thisoverall trend was not statistically significant, but significant trends in excess riskwere found in subgroups defined by cell type, age, and time after exposure. Thegreatest excess risk was found in those individuals in the high-dose group withacute leukemia who were younger than 20 years at exposure and who died before1964. These results are consistent with previous studies and with risk estimates forother populations exposed to radiation.

NO FUNDING FOR STUDY

Senator HARKIN. Have you ever applied to the Centers for Dis-ease Control?

Dr. LYON. We have approached them. They are interested in car-rying out the study, but have no funding for it, Senator.

Senator SPECTER. Dr. Lyon, we may not get to all the details inthe questions and answers, but to the extent you have a suggestionas to what agency ought to do the research and what kind of fund-ing is necessary, this is something that we might even be able toaccommodate at this late date on our conference report.

Dr. LYON. We have a request for about $1.9 million in that Sen-ator Bennett has made.

Senator SPECTER. $1.9 million?Dr. LYON. $1.9 million per year for the next 5 years.Senator SPECTER. That might be accommodated in a $79 billion

budget.

26

Dr. LYON. That also I believe covers research on the Indiangroups in Nevada also.

Senator REID. Who does he recommend do it?Dr. LYON. I would suggest the Centers for Disease Control, be-

cause of their long involvement with public health and with publicinvolvement in their research process.

Senator SPECTER. Let us move ahead now to Dr. Beyea.Senator HARKIN. I just want to say one thing for the record, Mr.

Chairman. I am with you on that, but I want to make sure thatany grant application that comes in does go through the rigorouspeer review process that has been established.

Dr. LYON. Well, we survived that once, Senator.

STATEMENT OF JAN BEYEA, Ph.D., SENIOR SCIENTIST, CONSULTINGIN THE PUBLIC INTEREST

ACCOMPANIED BY LAWRENCE MAYER, M.D., BIOSTATISTICIAN ANDCLINICAL INVESTIGATOR, JOHNS HOPKINS AND ARIZONA STATEUNIVERSITIES

SUMMARY STATEMENT

Senator SPECTER. Our next witness is Dr. Jan Beyea, a seniorscientist at the firm Consulting in the Public Interest. Dr. Beyeahas written extensively on the radiation health effects of ThreeMile Island and other nuclear incidents. We thank you for comingand look forward to your testimony.

Dr. BEYEA. Thank you, Senators. I have asked Dr. LawrenceMayer, who is a biostatistician and clinical investigator at JohnsHopkins and Arizona State University, to come in case there areany questions to answer. He has also generously agreed to hold upa poster here that I am going to show you in a minute, if I could.

I have only a few points to make. First of all, as a dose re-constructionist I think that the numbers in the NCI report aresomewhat understated.

Senator REID. As a what? I could not understand.Dr. BEYEA. A dose reconstructionist, one who does the same kind

of work as done by the NCI researchers.I think the numbers are probably understated to a certain extent

to make the things look a little better.My second major point has to do with the actual health effects.

If I could have that poster, Dr. Mayer.Dr. Mayer and I have both researched the world’s literature on

thyroid effects, and what we are concerned about is that attentionhas focused almost exclusively on cancer and there are a numberof other health effects that are probably more likely to have oc-curred in the population than thyroid cancer.

What I have done here is I have listed under the first columnvarious cancer diseases, those which were mentioned in the NCIreport, when it was known scientifically when these health effectswould occur, and finally what the lowest dose that has been con-firmed in the literature. These numbers do not mean that these ef-fects cannot occur lower than that, but these have been confirmedin the literature at these doses.

So we go over to cancer. That has been well discussed. Butnodularity, a lesser degree, which includes cancer, includes adeno-

27

mas. Sometimes these have to be surgically removed. You are goingto find more nodules than you are going to find cancer.

Autoimmune thyroid disease includes hypothyroidism, chronicthyroiditis. These are diseases that are relatively mild, but theyare still important. They are more likely to occur than cancer. Themost likely way they are occurring at low dose radiation is throughthe autoimmune process, a process where the radiation triggers inthe body our own immune system and our own immune system be-gins to attack our thyroid cells and, after many, many years,causes thyroid disease.

In fact, these effects didn’t show up in the A-bomb survivorsuntil 40 years after the bomb was dropped, which means that theseshould just now begin to be showing up in the population that wasexposed in the fifties and sixties in the United States.

This was all known. It has been known for many years now. AndI do hope, and Dr. Klausner assures me, that this now will belooked at by the Institute of Medicine. But I do hope you in thispanel in front of us will also make some attempt to make sure thatthis is considered in the assessment of what is done as a follow-up to this.

It is my belief and Dr. Mayer’s belief, having looked at this, thatwe really do need a medical surveillance program that will allowdoctors to be acquainted with this effect, which is fairly new, tolook for these. It involves thyroid scans and also some blood tests,the additional medical tests that you would do to find these auto-immune thyroid diseases.

Senator HARKIN. May I just interject, Dr. Beyea?Dr. BEYEA. Yes, please do.Senator HARKIN. The autoimmune thyroid disease, you just said

the lowest dose confirmed. What does that mean? Explain thatagain, please?

Dr. BEYEA. It means that at Chernobyl, for instance, there werethousands of children who were irradiated. At 15 rads of exposure,the population is showing excess elevated thyroid antibodies, whichare an indication that the autoimmune process has started, hasbegun in those children, and that years later they will develop,some of them, a fraction of them will develop, hypothyroidism.

Now, not every scientist agrees with this, by the way. There issome debate in the scientific literature about this. But it is cer-tainly something that needs to be considered in any medical sur-veillance program. It is cheap to look for. It is easy to find and itshould be part of the process.

There is another study that was done in 1988 by Kaplan thatshowed between 10 and 112 rads there was a doubling in this kindof process. Nagataki did a study in 1994 at Hiroshima—at Naga-saki, which showed an increase, a doubling increase in this kindof disease in the atom bomb survivors at about 40 rads.

So the literature show somewhere between this range is perhapswhere you start, where you start looking for it.

Senator HARKIN. So what you are saying is that the NCI reportlooked just at cancer.

Dr. BEYEA. That is right.Senator HARKIN. And that they did not look at nodularity or

autoimmune thyroidism?

28

Dr. BEYEA. Let me clarify. In the materials—I see Dr. Klausnershaking his head here. In the materials that have been circulatedabout this report, there has been only mention of cancer that Icould find. There has been no mention that there is likely threetimes as much adenomas. There has been no mention of low doseautoimmune thyroid disorder.

Senator SPECTER. Dr. Klausner, you have shaken your head no.We will give you a chance right now for a 1-minute response tothat.

Dr. KLAUSNER. It is just that this particular report is only look-ing at dose estimates and exposure estimates. As I said, this reportdoes not talk about thyroid cancer.

Dr. BEYEA. But the materials you circulated, but the materialyou circulated, in which you described, and I think very rightly—you did a good job in talking about the issues of thyroid cancer andthat is naturally what most people focus on. But my suggestion isthat in future documents that you also consider these othernodularities and autoimmune thyroid conditions.

Senator SPECTER. Is Dr. Beyea right about that, Dr. Klausner?Dr. KLAUSNER. Whether that in the future we ought to look at

these things? We have not limited the Institute of Medicine inwhat they are looking at in terms of health consequences as wellas in terms of thyroid consequences.

Senator SPECTER. You have not limited it, but would you askthem to include what Dr. Beyea has said?

Dr. KLAUSNER. We are happy to do that, but we have asked themto look at all health consequences.

Senator SPECTER. We will pick this up later in the questions andanswers. Dr. Beyea, you have some more to say?

Dr. BEYEA. I have a quick conclusion, just a quick conclusion. Iwould like to suggest that it is very important that we look at whathappened and why things maybe were a little slow, but it is alsoimportant that we think about taking action. That involves a medi-cal surveillance program, giving information to citizens as to whatearly science might be of various kinds of diseases.

PREPARED STATEMENT

Finally, I think we have to be prepared to give medical treatmentto those areas where people are not adequately protected by medi-cal insurance.

[The statement follows:]

PREPARED STATEMENT OF JAN BEYEA, PH.D. [1]

I have asked Dr. Lawrence Mayer [2] to accompany me here today to answer anymedical questions related to the work I will be discussing. For this hearing, I re-viewed the NCI’s exposure calculations based on the preliminary information pub-lished by NCI on its study, [3] as well as other uses of the databases relied uponby NCI. [4] In connection with litigation over radioiodine releases from the Hanfordproduction facility, Dr. Mayer and I have also reviewed the scientific literature onthe health effects associated with low-dose exposure to radioiodine, which has madeus sensitive to disease risks other than thyroid cancer.

Since NCI in its preliminary reports has only discussed the possible connectionbetween radioiodine exposure and thyroid cancer, I will focus most of my attentionon thyroid nodules and autoimmune thyroid diseases. Based on my studies andthose by Dr. Mayer, I have reached a number of conclusions:

29

1. The ‘‘gummed paper’’ data, which NCI used to calibrate its estimates ofradioiodine exposure, are probably free from the political pressures of the time and,therefore, can be used as the basis for unbiased exposure estimates.

DOE’s Health and Safety Lab (HASL, now EML), an institution that has alwaysprided itself on its independence and integrity, carried out the measurements of fall-out radioactivity on gummed paper at the time. Having been privy to EML practicesas part of discovery in legal cases, [5] I have seen evidence of HASL scientists resist-ing orders to suppress information, finding ways to make the information public.There may be mistakes and limitations in the underlying gummed-paper data, butthey are probably honest mistakes and limitations.

2. Nevertheless, there are a number of reasons to expect that the current best es-timates for exposure may be low.

Generating historical exposure estimates requires making judgments, particularlyin choosing values for parameters that enter the exposure model. It is difficult, evenwithout the political pressure that radiological dose estimates have engendered, topick an unbiased set of best-estimate parameter values. Thus, the choice of studymembers and the makeup of advisory committees can play a crucial role in a study’soutcome, and hence can generate ferocious infighting. Usually, there are many freemodel parameters to specify in a dose reconstruction exercise. A member of the ana-lytical team with a strong particular bias, or a member of an advisory committeewho believes he or she knows the ‘‘correct’’ answer, not to mention the employersof the team, can selectively, even unconsciously, bias some of the results for non-scientific reasons. Without countervailing critiques of the choices made for impor-tant parameters, analysts may adjust parameters to satisfy advisory committees, su-pervisors, or dominant team members. Only if the advisory committees have a fullrepresentation of independent scientists with varying points of view can the choiceof parameter values be kept from favoring the perceived goals of one political factionor agency. I have found some hints of this phenomenon in the early descriptions ofthe work provide by NCI. [6] Congressional investigators should scrutinize themakeup of the various advisory committees over time, the process by which studyleaders and members were chosen, and whether or not independent scientists wereappointed as members. Investigators should also examine if NCI was prepared tohandle the heavy politicization that has existed in this country over radiation healtheffects. I have a very high degree of respect for NCI, based on personal experienceand knowledge of its work. NCI has done many marvelous studies. It has a topnotch, peer-review process for scientific projects, but it may not have been preparedfor the hard-ball politics that was played with radiation health effects by other gov-ernment agencies and influential figures. It would be a tragedy if public confidencein NCI were undermined because of this incident. Full and open disclosure at thispoint is the best way to protect the reputation of NCI. [7]

3. The uncertainties in the dose estimates may have been understated in thecounties with lower exposure.

Published articles dealing with the underlying databases have pointed out certaininconsistencies in estimates made outside the highest dose regions. [8] The incon-sistencies imply that the uncertainties in the lower dose regions are likely to begreater than stated in the NCI report. Thus, it may be unwise to dismiss consider-ation of medical actions in these areas, based solely on the dose ranges provided inthe NCI report.

4. The NCI reports published to date have ignored diseases other than thyroidcancer.

Thyroid nodules, another known consequence of radiation exposure, have been ne-glected by NCI, even though such nodules require follow-up, and sometimes surgery.The authors of the thyroid disease study carried out around the Nevada Test Sitewere much more than ‘‘suggestive’’ when it came to induced neoplasms:

‘‘We conclude that in the cohort that was studied, an excess of between one and12 neoplasms (0 to six malignancies) was probably caused by exposure to falloutradioiodines from nuclear weapons testing.’’ [9]

The NCI report is strangely silent on this consequence of radioiodine exposure.Of great concern is that physicians should be alerted to watch for signs and symp-

toms of lesser diseases than thyroid cancer, namely autoimmune hypothyroidism,mild thyroiditis, and possibly hyperthyroidism incident to Graves’ disease. Thesediseases can be initiated by low to moderate radiation doses, the recent literaturesuggests, presenting themselves years after exposure. They are most likely causedby an autoimmune reaction in susceptible individuals. Once triggered, the body at-tacks its own thyroid cells, eventually causing clinical disease. Such effects were notidentified in the A-bomb survivors by Nagataki et al. until 40 years after the bomb-ing of Japan. [10] This finding suggests that these diseases should now be evident

30

in the US population exposed to fallout doses of about 40 rads, assuming that theA-bomb situation is comparable. [11]

The extensive data collected on people living around the 1986 Chernobyl disastershow that radioiodine exposure at surprisingly low doses—between zero and 30rads, mid-point equals 15 rads—leads to significant production of antithyroid anti-bodies. [12] The dose response stays fairly flat as dose increases up to a few hun-dred rads suggesting that a susceptible subgroup exists that is sensitive to lowdoses. Now, the presence of antibodies alone does not necessarily imply any diseasesare yet present in this population, neither autoimmune thyroiditis, nor autoimmunehypothyroidism, nor autoimmune hyperthyroidism. However, the presence of ele-vated thyroid antibodies is a well-known risk factor for chronic thyroiditis andhypothyroidism. [13], [14]

Most of these data on autoimmune thyroid disease are new [15] and contradictsome older published work. [16], [17], [18] The major study of the Nagasaki popu-lation wasn’t published until 1994 [19] and the striking thyroid antibody study onthe Chernobyl population wasn’t published until 1996. [20] Although not yet appre-ciated or accepted by all scientists, the new information contained in these studiesneeds to be communicated to physicians and other health providers practicing inthose counties where exposures may have exceeded an appropriate threshold, takenhere to be 15 rads. Since exposure uncertainties may be as high as a factor of ten,these diseases could be appearing today in counties with average exposures as lowas 1.5 rads. [21]

5. I question if NCI has the full range of expertise necessary to consider thesenon-cancerous, autoimmune diseases in its contract with the Institute of Medicine.

An important question is whether or not the contract NCI has developed with theInstitute of Medicine will allow the Institute to consider this new literature in de-tail, as well as its importance for medical surveillance. Possibly, other divisions ofNIH with expertise in autoimmune diseases, including immunology and endocrinol-ogy, should have a role in the follow-up study NCI has commissioned.

6. A medical response program is in order for a significant fraction of the UnitedStates population exposed to fallout.

Such a program should deliver medical information to physicians, perhapsthrough medical societies or continuing education. It should inform exposed personsof the early or pre-clinical symptoms of disease. It should provide medical surveil-lance in areas where the prior likelihood of disease is likely to be significant. Fi-nally, in such areas, it should provide treatment for persons with a wide range ofthyroid diseases who do not have adequate medical care due to insurance limita-tions.

Obviously, a great deal of thought needs to be given to designing a proper medicalsurveillance program. However, based on the review of the literature and on discus-sions with Dr. Mayer, it seems clear that a carefully designed program would pro-vide tremendous health benefits for those who do not already have, or do normallytake advantage of, regular and thorough medical care. [22], [23] The monitoring ef-forts required will generally not entail a large individual expense, although the totalfor the country will be significant. A surveillance program might consist solely ofregular thyroid palpations and blood tests for thyroid dysfunction, including a‘‘TSH’’ assay.

Diseases that should be monitored:A. Thyroid cancer and its typical precursor, thyroid nodularity.As has been discussed by NCI, cancer risks are heavily weighted towards those

exposed as children, particularly those exposed at the ages of 0–4 years. For exter-nal radiation, cancer has been confirmed in the literature down to an average doseof 9 rads, [24] and there is no evidence of a threshold to suggest cancer cannot becaused down to lower doses. Even if iodine-131 exposure were to be somewhat lessof a risk factor for cancer compared to external radiation, this reduced risk wouldnot change the fact that disease will result from the weapons fallout. It would onlychange the expected number of cases.

B. Autoimmune thyroid diseases should also be monitored, particularly auto-immune hypothyroidism, autoimmune thyroiditis, as well as hyperthyroidism inci-dent to Graves’ disease. [25]

The lowest dose in the literature shown to trigger the autoimmune thyroid processis found in a study of Chernobyl-exposed children. It is 15 rads. [26] An importantgoal of a medical surveillance program for autoimmune thyroid diseases, in additionto identifying any severe cases that have been missed, should be to identify mildand subclinical cases of hypothyroidism, which are difficult to detect and easily con-fused with non-disease conditions. Studies show that people with subclinicalhypothyroidism benefit from drug treatment, leading to improved quality of life. [27]Paradoxically, severe cases are easily identified and easily treated with corrective

31

medicines. Mild cases can go on for long periods of time, reducing the quality of lifefor people until symptoms get so severe that the need for treatment is recognized.

Although it is now clear that those children who drank milk at the time of expo-sure are the key population to monitor for thyroid nodularity and cancer, the effectsof exposure age on the risk of autoimmune disease is not known. This uncertaintycomplicates the picture for determining the scope of a medical surveillance programfor radiation-induced autoimmune diseases.

7. Information on the importance of the food chain for radiation exposures hasbeen known for a long time. Government health physicists have known of the impor-tance of the food pathway as a source of exposure since 1946. [28] They knew aboutthe value of early intervention by, at least, 1958. [29] By the time of many, if notall, of the weapons tests, government officials knew or should have known that amitigation strategy would prevent injury. Advisories to the public to avoid drinkingfresh milk after weapons tests, particularly after rain, could have significantly re-duced the expected number of thyroid cancer and nodules (and, as we now know,non-functioning thyroids). Such advisories could have been presented simply as aprecaution, without having to admit to the public that any harm would necessarilyfall upon them. Obviously, such a warning might have weakened public support fornuclear weapons testing and, therefore, would have had to be balanced againstissues of national security. Somewhere, there may exist records of high level discus-sions about this difficult choice. Their content may be very revealing in helping todetermine the degree of responsibility owed by the government to the public for thehigh exposures.

8. It was not necessary to know the full outcome of the NCI study before makingrecommendations on medical surveillance. By 1982, when Congress asked NCI toundertake the fallout study, the connection between thyroid cancer and radioiodinewas well known. At what point should NCI or DOE have taken steps to inform themedical community about the potential risks to their patients? Answering this ques-tion will, no doubt, be a key goal of congressional investigations.

9. There may be other relevant studies languishing under bureaucratic confine-ment

The fact that NCI has taken so long to report the essential public health messagein this work raises questions about other studies that may be ongoing. [30] For in-stance, are political pressures slowing reports of the NCI’s Chernobyl study? Willthe Institute of Medicine have access to the preliminary results? Are there pendingstudies in other government agencies, such as DOE, that bear on the questions be-fore the committee?

CONCLUSION

There are a number of factors that suggest a medical information, surveillance,and treatment program is in order for those exposed to weapons test fallout. Thesefactors are (1) the magnitude of the projected radioiodine exposures, (2) the largeuncertainties in the estimates, and (3), the recent findings that autoimmune thyroiddiseases can be triggered at relatively low doses of radiation.

I hope that the need for action not be forgotten as attention focuses on why therehas been such a delay by government agencies in formulating a recommendation onmedical surveillance.

ACKNOWLEDGEMENTS

I thank Dr. Mayer for advising me on the medical aspects of my statement andJoseph Wayman and David Beavers for collecting some of the historical documentsrelating to the discovery of the food exposure pathway for radioiodine

REFERENCES

[1] Correspondence relating to this testimony should be sent to Dr. Beyea atjbeyea@cipi.com. Dr. Beyea is Senior Scientist at Consulting in the Public Interest,Lambertville, NJ. Web page: www.cipi.com. He has performed dose reconstructionsused in epidemiology studies at TMI, e.g., ‘‘Cancer Rates after the Three Mile IslandNuclear Accident and Proximity of Residence to the Plant’’, (Hatch, Wallenstein,Beyea, Nieves, Susser), American Journal of Public Health, 18(6), June 1991; ‘‘Can-cer Near the Three Mile Island Nuclear Plant: Radiation Emissions’’, (Hatch, Beyea,Nieves, Susser), American Journal of Epidemiology, Sept. 1990.

[2] Dr. Mayer is a biostatistician and clinical investigator currently on the facultyof Johns Hopkins Schools of Public Health and Medicine, Baltimore, Maryland;Good Samaritan Medical Center, Phoenix, Arizona; and Arizona State University.

[3] National Cancer Institute, Press Kit, August 1, 1997.

32

[4] Thompson, CB and MacArthur, RD, ‘‘Challenges in Developing Estimates ofExposure Rate Near the Nevada Test Site, Health Physics, 71: 470–476, 1996. Seealso: Kirchner et al., ‘‘Estimating Internal Dose Due to Ingestion of Radionuclidesfrom Nevada Test Site Fallout, Health Physics, 71: 487–495, 1996; Till et al., ‘‘TheUtah Thyroid Cohort Study: Analysis of the Dosimetry Results,’’ Health Physics, 68:472–483, 1995; Simon, SJ et al., ‘‘The Utah Leukemia Case-Control Study: Dosim-etry Methodology and Results,’’ Health Physics, 68: 460–471, 1995.

[5] I have reviewed internal EML documents in connection with a pending classaction suit at the Rocky Flats plutonium finishing facility.

[6] Analysts had to pick a best estimate for the ‘‘intake-to-milk’’ transfer coeffi-cient. The NCI report states, ‘‘Reported literature values range from 2 x 10¥3 to 4x 10¥2 d L¥1 but it seemed that fallout studies yielded values in the lower partof the range. For the purposes of this report, it is assumed that the median valueof fm for 131I and for cows is 4 x 10¥3 d L¥1.’’ In my experience, such vague lan-guage is sometimes a signal that decisions have been made for non-scientific rea-sons. Although this may not be the case here, the vagueness of the reasons givenfor using a lower than average value provides justification for scrutinizing the deci-sion process that was used to choose parameter values.

[7] I am concerned, therefore, about the equivocal language that still remains inthe NCI’s press material of August 1, 1997, particularly in the July 1997, ‘‘Back-ground Information on Thyroid Cancer and Radiation Risk,’’ which was included inthe new packet. It reads like a press release from the old Atomic Energy Commis-sion.

[8] Thompson et al., op. cit., p 473.[9] Kerber, RA, Till, JE, Simon, SL, Lyon, JL, et al., ‘‘A Cohort Study of Thyroid

Disease in Relation to Fallout from Nuclear Weapons Testing.’’ JAMA, 270: 2076–2082. 1993.

[10] In a dose range from 0- to 100-rads. The response curve was non-linear.Nagataki, S. et al., ‘‘Thyroid diseases among atomic bomb survivors in Nagasaki.’’JAMA 272 : 364–371 (1994).

[11] Although some scientists maintain that Iodine-131 is less effective than theexternal radiation delivered at Hiroshima and Nagasaki, few scientists would main-tain that there is no effect. Furthermore, Chernobyl data on children show the pre-cursors of these diseases, namely antithyroid antibodies in persons exposed to Io-dine-131 (World Health Organization, op. cit.).

[12] Levels of antithyroid antibodies have been measured in thousands of childrenat Chernobyl, demonstrating that these precursors of autoimmune disease have in-creased dramatically in those exposed to 0 to 30 rads. I take the mid-point of thisregion, namely 15 rads, as the practical threshold for a medical surveillance pro-gram aimed at autoimmune thyroid disease. (Souchkevitch, G.N. et al. eds. HealthConsequences of the Chernobyl Accident: Results of the IPHECA Pilot Projects andRelated National Programmes, Geneva: World Health Organization, pp. 264–68(1996).)

[13] I emphasize that the findings of antithyroid antibodies do not prove diseaseis yet present, only that the autoimmune process has started in the Chernobyl popu-lation. Progression to autoimmune thyroiditis and hypothyroidism, however, is ex-pected based on epidemiological surveys of the background incidence of thyroid dis-ease in the general public. (Vanderpump, M.P.J. and Tunbridge, W.M.G. ‘‘The Epi-demiology of Thyroid Diseases’’ (1996), in Werner and Ingbar’s The Thyroid, 7th ed.,eds. Braverman, L.E. and Utiger, R.D., Philadelphia: Lippincott-Raven, pp. 474–482(1996). Also, Vanderpump, M.P.J. et al. ‘‘The incidence of thyroid disorders in thecommunity: a 20-year follow-up of the Whickham Survey.’’ Clinical Endocrinology43: 55–68 (1995). Relevant information can also be found in Weetman, A.P. ‘‘Chronicautoimmune thyroiditis,’’ in Werner and Ingbar’s The Thyroid, op. cit., pp. 738–48Also, Geul, K.W. et al. ‘‘The importance of thyroid microsomal antibodies in the de-velopment of elevated serum TSH in middle-aged women: associations with serumlipids.’’ Clinical Endocrinology 39 (3): 275–80 (1993). Also, Bilous, R.W. andTunbridge, W.M.G. ‘‘The epidemiology of hypothyroidism—an update.’’ Bailliere’sClinical Endocrinology and Metabolism 2: 531–540 (1988).

[14] The existence of these antibodies is often considered to be sufficient evidenceof subclinical autoimmune thyroiditis (Weetman, A.P. ‘‘Chronic autoimmune thyroid-itis,’’ in Werner and Ingbar’s The Thyroid, 7th edition, eds. L.E. Braverman andR.D. Utiger, Philadelphia: Lippincott-Raven, pp. 738–48 [1996]), because, for onereason, local thyroiditis is correlated with such antibodies at autopsy (Vanderpump,M.P. et al. ‘‘The incidence of thyroid disorders in the community: a twenty-year fol-low-up of the Whickham Survey,’’ Clinical Endocrinology 43: 55–68 [1995]).

[15] Although the early work by Malone and Cullen is consistent with theChernobyl antibody plateau. (The Lancet, July 10, 1976, pp 73–75.)

33

[16] Morimoto et al., J Nucl Med 28:1115–1122, 1987 used an earlier version ofthe A-bomb dosimetry, the so-called T65-dosimetry, that is now thought to be infe-rior to later dosimetry efforts (e.g., DS86). Morimoto is a 30-year follow-up studycompared to 40 years in the Nagataki study. Furthermore, the Morimoto group onlylooked at two data points, the 0 rads group and the 100∂ rads group. In otherwords, Morimoto skipped the dose region where Nagataki et al. found their greatestexcess. This choice reduces the number of cases compared to Nagataki. For all thesereasons, it is not surprising that Morimoto did not find a detectable effect.

[17] Yoshimoto et al., ‘‘Prevalence Rate of Thyroid Diseases among Autopsy Casesof the Atomic Bomb Survivors in Hiroshima, 1951–85, Radiation Research, 141:278–286 (1995), is an autopsy study of A-bomb survivors that looked at the condi-tion, ‘‘chronic thyroiditis.’’ This condition is similar to the positive-antibody, subclini-cal condition studied by Nagataki et al. Yoshimoto et al., assumed a linear responsecurve, which would have made the response less statistically significant. AlthoughYoshimoto et al. published their results in 1995, they analyzed autopsies between1951 and 1985. This means that the average time since exposure was much lessthan for Nagataki et al., who looked at live people in 1985–87. The paper byNagataki et al., clearly has a much longer study period.

[18] As for the study of Utah fallout by Kerber et al., op. cit., the lack of findingof an effect of low dose radiation on the risk of hypothyroidism in Utah is not thatsurprising. The doses covered by Kerber’s study are quite low, and Maxon andSaenger argue that the data may indicate a threshold around 10–20 rads. (Wernerand Ingbar’s The Thyroid, op. cit. pages 342–351.) Moreover, the results are neitherinconsistent with Nagataki nor the Chernobyl antibody data. Furthermore, theKerber study took blood samples on a narrower population than did Nagataki.Kerber only took blood samples from those people in the study group who firstshowed clinical evidence of thyroid problems, a potential statistical bias, whereasNagataki took blood samples from the entire cohort. Interestingly, a companionstudy of fetal exposures around the Nevada Test Site by Lloyd, Tripp and Kerber,Health Physics, 70: 559–662, 1996, shows, according to my analysis, a similar doseresponse curve for thyroiditis and hypothyroidism as found in Nagataki.

[19] Nagataki, S. et al., op. cit. Kaplan et al. were the first group to find indica-tions that autoimmune thyroid doses could be caused by moderate doses (around 60rads): Kaplan M.M. et al. ‘‘ Thyroid, parathyroid, and salivary gland evaluations inpatients exposed to multiple fluoroscopic examinations during tuberculosis therapy:a pilot study.’’ Journal of Clinical Endocrinological Metabolism 66: 376–382. (1988)

[20] Souchkevitch, G.N. et al. eds. Health Consequences of the Chernobyl Acci-dent: Results of the IPHECA Pilot Projects and Related National Programmes, Ge-neva: World Health Organization, pp. 264–68 (1996). See Also: Vykhovanets, E.V.‘‘Association between increased doses of Iodine-131 to the thyroid gland and auto-immune disorders in children living around Chernobyl,’’ Poster presented at theFebruary 1997 annual meeting of the American Association for the Advancement ofScience.

[21] I do not mention here individual variability, which increases the ranges ofdose that need to be considered.

[22] See Danese, M.D. et al. ‘‘Screening for mild thyroid failure at the periodichealth examination—a decision and cost-effectiveness analysis.’’ JAMA 276: 285–292(1996).

[23] I do not consider here the question of whether private health care companiesshould be reimbursed for treatments that they provide for thyroid conditions in thehighly exposed counties, nor whether affected citizens should receive compensation.

[24] Ron E, Modan B, Preston D, Alfandary E, Stovall M, Boice JD Jr. ‘‘ThyroidNeoplasia Following Low-Dose Radiation in Childhood.’’ Radiat Res 120: 516–531,1989; Ron E, Griffel B, Liban E, Modan B. ‘‘Histopathologic Reproducibility of Thy-roid Disease in an Epidemiologic Study.’’ Cancer 57: 1056–1059, 1986.

[25] Effects have been seen at doses of 30 to 200 rads. (Katayama, S.; Shimaoka,K.; Piver, M.S.; Osman, G.; Tsukada, Y.; and Suh, O. (1985) ‘‘Radiation associatedhypothyroidism in patients with gynecological malignancies.’’ J. Med. 16: 587–596.).Although there is less evidence in the literature for the association with hyper-thyroidism at low doses of radiation, it seems plausible that autoimmune hyper-thyroidism should eventually result, once the autoimmune process has started, andshould also be monitored.

[26] World Health Organization, op. cit.[27] Arem, R. and Escalante, D. ‘‘Subclinical hypothyroidism: epidemiology, diag-

nosis and significance.’’ Adv Intern Med 41: 213–250 (1996).[28] As part of the production of the first atomic bombs, large amounts of

radioiodine were released into the atmosphere at the Hanford weapons facility inWashington. Accumulation of radioiodine in sheep was discovered around Hanford

34

as early as 1946. (Healy, JW, ‘‘Accumulation in the thyroid of sheep grazing nearHEW,’’ Hanford report, HW3–3455, March 1946. See also: Parker, H.M. 1946. Toler-able Concentration of Radio-iodine on Edible Plants. Hanford Atomic Products Oper-ation, G.E., Richland, Washington. NTIS, HW–7–3217.) Beginning in 1950, sci-entists at the Experimental Animal Farm at Hanford fed radioiodine to sheep andstudied thyroid damage. This information was all classified. By 1955, the food path-way had been discovered, ‘‘The principal hazard of iodine release to the environsarises from deposition in vegetation and subsequent ingestion by animals and hu-mans’’ (OM Hill, ‘‘Symposium on Iodine Problem,’’ Hanford report, HW–039073).Limits were set on consumption of contaminated milk. These findings were publiclystated at least by 1955: ‘‘Two significant routes of entry are consumption of freshgarden produce, and drinking milk from cows on contaminated pasture.’’ (Parker,H.M. 1955. Radiation Exposure from Environmental Hazards. Hanford Atomic Prod-ucts Operation, G.E., Richland, Washington. NTIS, Prepared for International Con-ference on the Peaceful Uses of Atomic Energy. p. 6.).

[29] By 1958, it was even known that intake of normal iodine could block the up-take of radioactive iodine in sheep (Bustad et al., American Journal of VeterinaryResearch, Vol 19, p. 250., October 1958).

[30] This is not the only time in recent years that efforts have apparently beenmade to delay publication of politically sensitive studies involving fallout hazards.As part of an agreement over discovery in the Hanford litigation, I was allowed toread a controversial draft manuscript by Musolino et al. that recalculated exposureto the Marshallese following early weapons tests in the Pacific. At the time, DOE’sBrookhaven Laboratory was withholding publication of this report, and, to this date,we have still not been apprised of its release. Only vigorous oversight by Congresscan override the bureaucratic temptation to delay unpleasant information as longas possible, even though valuable time may be lost in providing early detection ofmedical conditions.

INSTITUTE OF MEDICINE

Senator SPECTER. Dr. Beyea, would you specify in writing for thesubcommittee exactly what you think ought to be done with respectto the particularities you just mentioned?

Dr. BEYEA. To a certain extent I have done that in my writtenstatement. I would be glad to do that. I have a lot of confidencein the Institute of Medicine if they have a contract which is writtenproperly that will allow them to look at all these issues and if theybring in the right people.

So if we can do that and make sure there is a broad representa-tion on the Institute of Medicine’s panel, I am confident the Insti-tute will bring this to the forefront.STATEMENT OF TIMOTHY CONNOR, ASSOCIATE DIRECTOR, ENERGY

RESEARCH FOUNDATION

Senator SPECTER. We now turn to Mr. Timothy Connor, associatedirector of the Energy Research Foundation in Spokane, WA. Mr.Connor has published several articles on low dose radiation andpublic health. Thank you for joining us, Mr. Connor. The floor isyours.

Mr. CONNOR. Thank you, Senator Specter. Thank you, SenatorHarkin, for the invitation this morning. I will try to keep my re-marks to 3 minutes.

I come here this morning with the hope that today’s hearingbrings us near——

Senator SPECTER. If you spill over a little, it is OK.Mr. CONNOR [continuing]. Brings us nearer to closing the circle

of accountability and reconciliation around one of the more difficultproblems in our country’s history. My mother’s family is fromPasco, WA, just a few miles downstream from the Hanford NuclearReservation along the Columbia River.

35

And as it turns out, I was actually born at an Army hospital atHanford in 1956 while my dad was on active duty in Korea.

It was not until the 1980’s that the term ‘‘Hanford downwinder’’came into wide usage in eastern Washington. This is because itwas the spring of 1986 before citizen activists and journalists fi-nally succeeded in forcing the Federal managers of the Hanfordsite to make public the historical documents proving what manypeople in our part of the world already suspected: In their hasteto manufacture the plutonium used in America’s first nuclearweapons, the operators of Hanford’s plutonium processing plantshad released hundreds of thousands of curies of iodine-131 into theatmosphere.

The Hanford revelations had a profound effect on public debateand public sentiment in eastern Washington and throughout theNorthwest. While scientists continue working to better answer thequestion of how widely people were exposed and how many cancersand other illnesses can be attributed to the emissions, there isoverwhelming sentiment that what happened was wrong. Civilizedgovernments are not supposed to expose their citizens to radiationor other hazards without bothering to warn them or, worse, go fordecades without alerting them to the continuing health risks of theexposures.

This conclusion is shared by people who have vastly differentviews about nuclear weapons. Eastern Washington is a rather con-servative place and many people are understandably proud of Han-ford’s historic role in forcing an end to the war with Japan. Still,patriotism does not allow us to excuse what happened to people liv-ing downwind of Hanford during the forties and fifties.

Perhaps the hardest thing for people to accept was the knowl-edge that the Federal Government hired and was paying people atHanford to study exposures and the biological and health effects ofradiation and yet for three decades the truth about the Hanford re-leases was withheld. For three decades people were regularly as-sured their health was being protected. Even on the day that Fed-eral officials released the documents disclosing the radiation re-leases, one of them stood behind a podium with a Federal seal onit and said: ‘‘There is no reason to expect observable harm.’’

Regardless of how people in the Columbia basin felt about pluto-nium, the bomb, the war, and the hundreds of millions of dollarsa year coming to Hanford, there is little question now about howthey feel about being lied to, even if the lies were cleverly composedlies.

What happened at Hanford is relevant to today’s hearing for tworeasons. The first is that the circumstances surrounding the Na-tional Cancer Institute’s handling of the radioactive iodine falloutstudy are remarkably similar to those surrounding the Hanfordemissions. While it is true that NCI did not create the fallout, itwas charged with the important task of telling Congress and theAmerican people about what happened.

The Institute failed in this responsibility. It failed because its re-searchers some time ago had compiled and analyzed enough evi-dence to realize that this was more than just a science project.They knew or should have known that at least thousands of infantsand children throughout America had received thyroid doses put-

36

ting them at substantially greater risk for thyroid cancer and otherthyroid diseases. People had a right to know and had they knownthat knowledge may well have made a difference in their lives.

The hardest thing to accept is that once again Federal scientistsand officials chose to withhold information vital to the health andwellbeing of citizens whose interests they are supposed to be serv-ing. Once again, people are outraged with the knowledge that theirillnesses might have been prevented or their suffering diminishedif only they had been told they were at greater risk due to theirexposures.

Once again, people feel like nuclear age guinea pigs or mere sta-tistics, as though the Government has infinitely more interest instudying them than in helping them.

The second reason the Hanford experience is relevant to thisstudy is that we were supposed to have learned from Hanford, andnot only from Hanford, but from all the other disturbing revela-tions of the 1980’s and before about the way Federal science hasbeen compromised in the field of radiation and health. We haveknown for many years that it was a mistake to allow the Depart-ment of Energy and its predecessors to dominate the avenues andprocesses by which the Government is supposed to be protectingpublic health and the environment from the effects of the Nation’snuclear weapons production and testing activities.

Part of this domination involved the control of DOE and its pred-ecessors exercise over health and health-related research activitiesinvolving radiation exposures to workers and the public.

I want to conclude by mentioning that former Energy SecretaryJames Watkins in 1990 acted on these criticisms by signing amemorandum of understanding [MOU] with the Department ofHealth and Human Services which transferred analytic epidemio-logic studies through this memorandum to HHS. Those studieshave been located in the Centers for Disease Control, where theCenter for Environmental Health looks at populations and the Na-tional Institute of Occupational Safety and Health looks at workerstudies.

It is interesting that NCI was left out of these reforms, and thesereforms were intended to allow the kind of sunshine, the publicoversight and communication that was not present in the study.This is a part of history we need to look at and make sure that,even though it is important, as the two doctors said, to look at thehealth consequences of this, it is also important to keep our eye onthe necessary reforms. We cannot go through another round, yetanother round, in our history where the American people feel thatthe Government is holding out on them and not sharing with them,not sharing the responsibility for their experiences due to releasesthat the Government is responsible for.

So I would highly second Dr. Lyon’s comments. We have a struc-ture now that would allow us to provide this oversight and open-ness. It is important that we use it. In fact, I think it is time thatwe look at legislation to replace the so that these studies are recon-stituted at HHS, so that this kind of study never happens again.

37

PREPARED STATEMENT

One of the truly unfortunate things about this study is that itwas headed by a former Department of Energy official who man-aged it in much the way the Department of Energy managed somany studies that were discredited. We cannot allow that to hap-pen again, and if there is one thing that we do on the reform side,let us look at that and make sure this does not happen again.

Thank you.[The statement follows:]

PREPARED STATEMENT OF TIM CONNOR

I come here this morning with the hope that today’s hearing brings us nearer toclosing the circle of accountability and reconciliation around one of the more difficultproblems in our nation’s history. The problem, in a nutshell, is our profoundly un-easy experience as a democracy facing the social, technological, and moral chal-lenges of building, testing, and otherwise owning a large arsenal of nuclear weap-ons.

My mother’s family is from Pasco, Washington just a few miles downstream fromthe Hanford Nuclear Reservation along the Columbia River. As it turns out, I wasborn at an army hospital at Hanford in 1956 while my father was on active dutyin Korea. I live in Spokane, now, which is approximately a hundred miles northeastof Hanford.

It was not until the 1980’s that the term ‘‘Hanford downwinder’’ came into wideusage in Eastern Washington. This is because it was the spring of 1986 before citi-zen activists and journalists finally succeeded in forcing the federal managers of theHanford site to make public the historical documents proving what many people inour part of the world already suspected. In their haste to manufacture the pluto-nium used in America’s first nuclear weapons, the operators of Hanford’s plutoniumprocessing plants had released hundreds of thousands of curies of radioactive iodine-131 to the atmosphere.

The Hanford revelations had a profound effect on public debate and public senti-ment in Eastern Washington and throughout the Pacific Northwest. While scientistscontinue working to try to better answer the question of how widely people wereexposed and how many cancers and other illnesses can be attributed to the Hanfordemissions, there is overwhelming sentiment that what happened was wrong. Civ-ilized governments are not supposed to expose their citizens to radiation or otherhazards without bothering to warn them or, worse, go for decades without alertingthem to the continuing health risks of the exposures.

This conclusion is shared by people who have vastly different views about whetherwe need large numbers of nuclear weapons to defend ourselves. Eastern Washingtonis a rather conservative place and many people are understandably proud of Han-ford’s historic role in forcing an end to the war with Japan. Still, patriotism doesnot allow us to excuse what happened to people living downwind of Hanford duringthe 1940’s and 1950’s.

Perhaps the hardest thing for people to accept was the knowledge that the federalgovernment hired and was paying people at Hanford to study exposures and the bio-logical and health effects of radiation. And, yet, for three decades the truth aboutthe Hanford releases was withheld. For three decades people were regularly assuredtheir health was being protected. Even on the day that federal officials released theHanford historical documents disclosing the large radiation releases, one of themstood behind a podium with a federal seal affixed to it. He said, and I quote, ‘‘Thereis no reason to expect observable harm.’’

Regardless of how people in Pasco, Ritzville, Dayton, Pendleton, Spokane, and inthe fields above Eltopia felt about plutonium, the bomb, the war, and the hundredsof millions a year in federal dollars coming to Hanford, there is little question nowabout how they feel about being lied to, even if the lies were cleverly composed.

What happened at Hanford is relevant to today’s hearing for two reasons.The first is that the circumstances surrounding the National Cancer Institute’s

handling of the radioactive iodine fallout study are remarkably similar to those sur-rounding the Hanford emissions. While it’s true that NCI didn’t create the fallout,it was charged with the important task of telling Congress and the American peopleabout what happened. It failed in this responsibility. It failed because its research-ers, some time ago, had compiled and analyzed enough evidence to realize that thiswas more than just a science project. They knew, or should have known, that at

38

least thousands of infants and children throughout America had received thyroiddoses putting them at substantially greater risk for thyroid cancer and other thyroiddiseases. People had a right to know. And had they known, that knowledge maywell have made a difference in their lives.

The hardest thing to accept is that once again, federal scientists and officialschose to withhold information vital to the health and well-being of citizens whoseinterests they are supposed to be serving. Once again people are outraged with theknowledge that their illnesses might have been prevented, or their suffering dimin-ished, if only they’d been told they were at greater risk due to their exposures. Onceagain people feel like nuclear age guinea pigs or mere statistics—as though the gov-ernment has infinitely more interest in studying them than in helping them.

The second reason the Hanford experience is relevant to this study is that wewere supposed to have learned from Hanford. And not only from Hanford but fromall the other disturbing revelations of the 1980’s, and before, about the way federalscience has been compromised in the field of radiation and health. We’ve known formany years that it was a mistake to allow the Department of Energy and its prede-cessors to dominate the avenues and processes by which the government is supposedto be protecting public health and the environment from the effects of the nation’snuclear weapons production and testing activities. Part of this domination involvedthe control DOE and its predecessors exercised over health and health-related re-search activities involving radiation exposures to workers and the public.

In 1990 the Department of Energy finally bent to Congressional and public pres-sure when Energy Secretary James Watkins signed a Memorandum of Understand-ing with Health & Human Services Secretary Louis Sullivan. This agreement, re-newed last year, transferred funding and managerial control over occupational andpublic health studies involving radiation exposures to the Centers for Disease Con-trol & Prevention and the National Institute for Occupational Safety and Health.

Just as importantly, the 1990 MOU initiated a process to enact long overdue re-forms in the way health and health-related studies involving public exposures wereto be conducted. Specifically, there were to be no more closed doors behind whichscientists worked without public oversight to decide how to study communities andwhat, if anything, to tell citizens about their exposures and health risks.

One glaring weakness in these reforms—a weakness vividly exposed by NCI’s mis-handling of the I-131 fallout study—is that there is still federally-funded radiationresearch, much of it being done at the National Cancer Institute, which proceedsoutside of the reforms enabled by the 1990 MOU. What is especially ironic in thisinstance is that the NCI fallout study was requested by Congress for the purposeof furthering the national accounting of health risks to the American people causedby U.S. nuclear weapons test fallout. And yet, it was managed by a former Depart-ment of Energy official in the same closed manner—without public oversight andmeaningful external review—that brought such discredit to the DOE radiation re-search program.

Surely, much work is needed to determine how the nation can and should respondto those who were put at substantially greater health risk due to the exposures thatthe NCI study appears to document. But I’d like to encourage the Subcommittee topursue and insist upon the steps that are needed to ensure that the importantscience that remains to be done in this area is done openly, with public oversightand robust independent peer review. The American people need to know, once andfor all, that federal scientific research addressing the health risks and consequencesof radiation and other hazardous substances is really being done on their behalf andnot on behalf of the institutional or political interests of government agencies andbureaucracies. While it is very late in the day to institute these reforms, it is abso-lutely necessary to see them through. It is an important part of making peace withour past and, more importantly, with ourselves.

One of the more disturbing aspects of the way the NCI I-131 fallout study wasconducted is that there was ample opportunity for NCI administrators to know bet-ter. It is hard to imagine how NCI officials could have missed the public controversyin the late 1980’s with regard to the conduct of radiation health research fundedthrough DOE. In August of 1989 Secretary of Energy James Watkins announced tothe Senate Governmental Affairs Committee that he would empanel some of the na-tion’s top health experts to review the issues and status surrounding DOE’s radi-ation health research program and report back to him with recommendations. Atthe time, there was legislation drafted by members of both the Senate and theHouse that would have formally transferred the radiation health research programto the Department of Health and Human Services.

The body Secretary Watkins appointed—the Secretarial Panel for the Evaluationof Epidemiologic Research Activities (SPEERA)—was chaired by Kristine Gebbie,then Washington state’s Secretary of Health. SPEERA reported its findings to Sec-

39

retary Watkins in March of 1990 and recommended several major reforms. A num-ber of the principles and recommendations advocated by SPEERA are worth revisit-ing in the aftermath of NCI’s mishandling of the I-131 fallout study. Among theprinciples SPEERA articulated were the following: [1]

‘‘The credibility of scientific research is essential and is directly dependent uponopenness. The benefit—credibility—derived from maximum public access to healthinformation greatly exceeds the risks of misuse or misunderstanding.’’

‘‘The findings of any epidemiologic research must be reported fully and promptlyto all who are affected.’’

‘‘The public has a right to know about collective health experiences and risks towhich they were exposed.’’

‘‘Epidemiologic findings must be reported fully and promptly to policy makers sothat findings are integrated into policy decisions.’’

While the NCI I-131 fallout study was not an epidemiologic study, it’s obviousthat the same principles would apply to exposure assessment studies.

The SPEERA panels’ recommendations were based on the above principles. Oneof its recommendations was that representatives of populations whose exposureswere being studied (and health officials who serve those communities) should be en-listed to serve on community level advisory committees. But perhaps its most impor-tant recommendation was for the creation of a new national advisory committee, tobe established by the Department of Health and Human Services, that would over-see epidemiologic research. It was this recommendation that was at the core of the1990 MOU between DOE and DHHS.

Among the other developments that should have gotten the attention of NCI ad-ministrators were the findings and recommendations of the Presidential AdvisoryCommittee on Human Radiation Experiments (ACHRE) in 1995. Although the Com-mittee’s primary concerns were the abuses involved with the use of human subjectsin radiation experiments, it also commented critically on how the culture of secrecywithin the former Atomic Energy Commission led to the suppression of informationinvolving exposures to the public from secret emissions at Hanford and other AECfacilities.

‘‘Where citizens are exposed to potential hazards for collective benefit,’’ the Advi-sory Committee observed, ‘‘the government bears a burden of collecting data neededto measure risk, of maintaining records, and of providing the information to affectedcitizens and the public on a timely basis.’’ [2]

Moreover, the ACHRE panel recommended the following with regard to futureknowledge of environmental exposures:

‘‘[the Administration] together with Congress, [should] give serious considerationto amending the provisions of the Radiation Exposure Compensation Act of 1990 toencompass other populations environmentally exposed to radiation from governmentoperations in support of the nuclear weapons program, should information becomeavailable that shows that areas not covered by the legislation were sufficiently ex-posed that a cancer burden comparable to that found in the populations currentlycovered by the law may have resulted.’’ (ACHRE Recommendation No. 5).

The reforms proposed by the SPEERA panel in 1990 are today being implementedthrough the MOU between DHHS and DOE, with cooperation from the Agency forToxic Substances and Disease Registry (ATSDR). Thus far, local or regional publicadvisory bodies have been established at the Hanford, Fernald (Ohio), SavannahRiver (South Carolina), and Idaho National Engineering & Environmental Labora-tory sites. Similar public advisory and oversight bodies have been created by agree-ments between the Department of Energy and the states of Tennessee and Coloradoto examine health issues surrounding the Oak Ridge and Rocky Flats sites respec-tively.

While these community-based advisory bodies do not guarantee a seamless resolu-tion to the health issues and concerns around these facilities, they do allow a trulyrevolutionary opportunity for public involvement that simply did not exist before the1990 MOU. This is the way democracy should work to resolve longstanding issuesand grievances that exist between a government and its people. This may seem likea messy and inefficient approach for some scientists and public officials but we’veseen the alternative and know it hasn’t served us very well.

Given the strides we’ve made in communities around DOE facilities to begin deal-ing openly with the unresolved public health issues related to historic emissions andwaste practices at these facilities, the complete failure of the NCI to notify and in-volve the public and public health officials in its I-131 fallout study is staggering.In my view, it represents a major setback for public trust and confidence in whathas otherwise been a commendable effort by DOE and DHHS in recent years.

Spokespersons for NCI have suggested that the delay in releasing the results ofthe NCI I-131 fallout study was due to the fact that it is a large study and that

40

researchers needed to make sure the exposure estimates were both thorough andcorrect.

The problem with this explanation is that it isn’t just the quality of the sciencethat matters. It wasn’t just livestock and gummed film sample plates that were ex-posed to the radiation NCI was asked to analyze. It was people. At some point inthe course of this study NCI researchers and officials knew, or had reason to know,that thousands of American infants and children had received thyroid doses thatwere orders of magnitude greater than Congress and the American people had beenled to expect. [3] At the very least, this knowledge should have led NCI to beginalerting and consulting with federal and state public health authorities, especiallythose responsible for public health in the areas hardest hit by the fallout.

Why NCI chose not to take this course is a matter of great concern and one forwhich the Subcommittee should seek a thorough explanation and accounting.

In conclusion, I would like to propose that the Subcommittee and Congress con-sider the following steps in response to NCI’s mishandling of the I-131 fallout study.

Consistent with the intent of the 1990 (and the 1996 update) of the MOU betweenU.S. DOE and DHHS, the National Cancer Institute’s radiation research projects—both domestic and foreign—should be brought under the purview of the HHS Advi-sory Committee on Energy-Related Epidemiologic Research. This reform could be ac-complished by a reorganization of an open, accountable, and effective radiationhealth research program within DHHS that would no longer be dependent uponfunding support from the Department of Energy.

This could be accomplished legislatively by replacing the MOU with a law estab-lishing a consolidated DHHS program charged with conducting and coordinatingfederal research on the public and occupational health effects of exposures to ioniz-ing radiation and other hazardous exposures related to nuclear weapons production,testing and nuclear facility operation. The program should have its own line itemin the DHHS budget. Under this initiative the charter of the HHS Advisory Com-mittee on Energy-Related Epidemiology should be amended and clarified. As partof this reform, it should be clear that the radiation health program that remainsat the Department of Energy is limited to those activities directly necessary to mon-itor the exposure and to provide for the daily occupational health needs of DOE em-ployees, and DOE contractor and subcontractor employees. All health studies ofthese workers should be done through HHS. All international research—such as thecurrent Chernobyl studies NCI is conducting with DOE funds—should be commis-sioned and funded through HHS and be accountable through HHS processes. Thischange should provide better accountability and enhanced credibility to the re-search.

If, for whatever reason, a legislative reform is not enacted, an Executive Branchreform could be accomplished by revising the Advisory Committee’s charter (whichis up for renewal in February) and having the charter signed by the Secretary ofDHHS. At the very least this involves amending the ‘‘Function.’’ description in theACERER charter to read:

‘‘The (ACERER) shall advise and make recommendations to the Secretary ofDHHS, the Secretary of Energy, the Assistant Secretary for Health of the Depart-ment of Energy, the Director of the Centers for Disease Control and Prevention, theAdministrator of the Agency for Toxic Substances and Disease Registry, and the Di-rector of the National Cancer Institute, on the establishment of the federal researchagenda pertaining to energy-related exposure and epidemiologic studies.’’

Whether by legislation or by Executive Branch reform, it is important the changebe accompanied with a commitment from NCI to participate with and be account-able to the Advisory Committee. The NCI Director should be asked to designate ahigh-level NCI official to be the liaison with the ACERER and this liaison shouldcommit to attending all regular ACERER meetings and participating in the fashionthat CDC, NIOSH, DOE and ATSDR now participate in that process.

NCI should be given a deadline (within 30 days) to review the reports of the 1995Presidential Advisory Committee on Human Radiations Experiments (ACHRE) andthe 1990 Secretarial Panel for the Evaluation of Epidemiologic Research Activitiesfor the Department of Energy (SPEERA), and from that review propose a set ofguidelines for public oversight, public participation, and external peer review of NCIradiation health studies that reflect the findings and recommendations of both bod-ies. These guidelines should include language that requires public notification anda public advisory process in circumstances where there is known to be, or discoveredto be, exposures that pose a significant threat to public health. These guidelinesshould be proposed to the Secretary of Health and Human Services and should bereviewed by the ACERER.

In addition, there are at least two non-policy initiatives that should occur as aresult of the long-delay in releasing the fallout data.

41

The General Accounting Office should be asked to investigate and report back toCongress on such issues as why the NCI failed to act on evidence indicating largenumbers of Americans received very high exposures, why the committee advisingNCI on the risk implications of the data was disbanded, etc.

In preparing this report, GAO should be asked to provide its own set of rec-ommendations along with its findings.

NCI should agree to support a process whereby CDC and the Agency for ToxicSubstances and Disease Registry convene a task force to examine the fallout data—including other radionuclides such as strontium-90 and cesium-137—the risk esti-mates, etc., and make recommendations to the Secretary of HHS with regard to theeducation, medical monitoring, and medical assistance steps necessary to adequatelyrespond to this information. This process should be coordinated with the ACERERand should include some ACERER members as well as representatives from stateand county health departments, citizen organizations with a history of interest inthese issues, other citizens who were exposed and who are representative of exposedgroups, and relevant medical experts. It would also be wise to have DOE participatein this process because, at the very least, they hold information that is likely toprove valuable to the task force.

REFERENCES

[1] Report to the Secretary, The Secretarial Panel for the Evaluation of Epidemio-logic Activities for the U.S. Department of Energy, March 1990.

[2] Final Report of the Advisory Committee on Human Radiation Experiments,1995. Finding No. 19.

[3] The National Cancer Institute Study: ‘‘Exposure of the American People to Io-dine-131 from Nevada Atmospheric Bomb Tests,’’ DRAFT memo, U.S. Departmentof Energy, July 29, 1997. p. 3.

FOLLOWUP STUDY

Senator SPECTER. Mr. Connor, again, to the extent that your pre-pared statement does not specify what you think ought to be doneby way of a followup study, the subcommittee would appreciate itif you would give us a written precise statement as to what youthink ought to be done.

Mr. CONNOR. I believe those are in my written comments to thesubcommittee.

Senator SPECTER. Thank you very much.Senator MURRAY. Mr. Chairman.Senator SPECTER. Senator Murray.Senator MURRAY. I have not made any statement yet. Mr. Con-

nor is from my State and I just want to have the opportunity tothank him for coming and let you know that he speaks on behalfof many Washington State citizens. I am the daughter of someonewho grew up in the Tri-Cities area, next to the Hanford NuclearReservation.

I heard you talk, Dr. Beyea, about expanding the studies beyondthyroid cancer. My father had multiple sclerosis, as do a largenumber of people in eastern Washington and Idaho, and no one hasever been able to connect that to radiation fallout. But I do thinkthe points being made are absolutely essential—that people havea right to know, that people need the information that we have aresponsibility to help those people, is absolutely essential.

Senator SPECTER. I quite agree, Senator Murray.

STATEMENT OF ANDREA McGUIRE, M.D., STAFF PHYSICIAN, VETER-ANS ADMINISTRATION HOSPITAL, DES MOINES, IA

Senator SPECTER. We now turn to Dr. Andrea McGuire, physi-cian at the Veterans Administration Hospital in Des Moines, a

42

graduate of Creighton University Medical School. Dr. McGuire hasseen many patients concerned about their fallout exposure.

Thank you for joining us, Dr. McGuire, and the floor is yours.Dr. MCGUIRE. Thank you, Senator Specter, and thank you, Sen-

ator Harkin, for inviting me.I am a nuclear medicine physician practicing in Des Moines, IA.

My profession involves the diagnostic and therapeutic use of radio-activity and the treatment and diagnosis of thyroid cancer. It iswith this knowledge and my own personal knowledge that I cometo this committee today.

My interest in this subject has been increased beyond my profes-sional interest by some medical events that have happened overthe last 12 years to my family. Several years ago my brother-in-law had a nodule found in his thyroid on routine examination.After further evaluation with imaging studies, there was suspicionthis was thyroid carcinoma and therefore he underwent a needlebiopsy.

At that time it was found to be thyroid carcinoma and he hada total thyroidectomy, which involves an incision across the neckand dissection of the thyroid gland. He then underwent thyroid ab-lation with radioactive iodine-131 and has routine followup to makesure he does not have recurrence of his disease.

Not long after my brother-in-law’s diagnosis, my sister-in-lawalso found a nodule in her thyroid. She too has been found to havethyroid cancer and has undergone a total thyroidectomy. Just re-cently, another one of my sisters-in-law has found a nodule and hasundergone a total thyroidectomy for thyroid cancer.

When I first became aware of the results of the fallout study, Iunderstood that some areas in Iowa had higher doses than others.When I discussed this with my mother-in-law, she told me that shehad lived in one of these areas during the time when these childrenthat had been exposed to this, when they were young, and theyhave gotten the thyroid cancer since.

They also were on a farm at this time and drank cow’s milk,which would increase their dose instead of getting milk from thedairy.

It worries me and concerns me that three of my husband’s familyout of seven, all in the immediate age with each other, have gottenthyroid cancer and would have gotten the highest dose from thisradiation fallout. As a physician, I am concerned because I takecare of these patients and I am not sure what to do for them.Should I have a higher suspicion when they come in the door ifthey have been in one of these areas?

I have heard a lot of information here today, but frankly in mypractice I have not heard this information. I am not sure what todo as far as should I do more studies on these people because theywill have a higher incidence? We have the external beam evidencethat shows that there is a higher incidence in those patients. Inthose patients we were very good about making sure they havemore testing and that we make sure that they do not get lost inthe system and that we make sure they do not have thyroid cancer.Should we be doing that on these patients?

43

I just do not have any information, Senators, to tell my patientswhat they should do or tell my siblings what they should do, andthis concerns me greatly.

PREPARED STATEMENT

In summary, the committee has the ability to give the physiciansthe information they need so that I can go to my patients and tellthem what they need to hear: whether there are risks to peoplewho are in the higher dose areas, what screening needs to be donefor these patients, are there studies that say that there is an in-crease, and how we should proceed to keep a higher cure rate forthyroid cancer in this country.

Thank you.[The statement follows:]

PREPARED STATEMENT OF DR. ANDREA MCGUIRE

My name is Dr. Andrea McGuire. I would like to thank the committee for invitingme to participate today. I am a Nuclear Medicine physician practicing in DesMoines, Iowa. My profession is involved with the diagnostic and therapeutic use ofradioactivity. This includes many patents being diagnosed and treated for thyroidcarcinoma. The radioactive fallout in the 1950’s and the resultant radioactive con-tamination in Iowa affects many of my patients. I am also a mother, and wife andsister to people affected by this radiation fallout.

My interest in this subject has been increased beyond my professional interest bysome medical events that have happened over the last 12 years in my husband’sfamily. Several years ago my brother-in-law had a nodule found in his thyroid ona routine examination. After further evaluation with imaging studies, there wassuspicion this was thyroid cancer and, therefore, he underwent a needle biopsy ofhis thyroid nodule. This showed thyroid carcinoma and my brother-in-law under-went a total thyroidectomy which involves an incision across his neck and the re-moval of the thyroid gland. He then underwent thyroid ablation with radioactive I-131. He continues on lifetime replacement of thyroid hormone as well as continuedyearly follow-up of his disease for recurrence. Not long after my brother-in-law’s di-agnosis with thyroid cancer, a physician’s examination revealed that a nodule waspresent in my sister-in-law’s thyroid. She also was eventually diagnosed with thy-roid cancer and underwent a total thyroidectomy and similar medical proceduresand additional treatments due to spread of her disease. Recently, another one of mysisters-in-law was diagnosed with thyroid cancer and underwent a total thyroid-ectomy.

When I first became aware of the results of this study of radioactive fallout andthat some areas in Iowa had received somewhat higher doses than others I dis-cussed with my mother-in-law where my husband’s family was living at the timesof these fallouts. She informed me that at that time their family had been livingin an area with the higher levels. After further discussion, I discovered that at thetime of the fallout her three children that now have thyroid cancer were under theage of 5 years old. This is important for two reasons: one, the amount of milk youngchildren drink is much greater than that which older children and adults consumeand two, the thyroid is thought to be more sensitive to radiation effects at thisyounger age. She went on to tell me that at that time they all lived on the farmand drank milk from their own dairy cow. This is important because typically themilk that goes to a dairy is consumed approximately 14 days from when it is milkedfrom the cow. But these children drank the milk within 12 hours from when it wasmilked from the cow.

With I-131 having an 8 day half-life, this would have given them approximately4 times the dose of people who consumed milk from the dairy. As a physician andscientist, I realize that there is no definite evidence that my family’s thyroid cancersare related to the exposure they received as children. However, the fact that thethree children who received the higher doses because of their location at the timeof the nuclear test, their age, and their ingestion of cow’s milk have all had thyroidcancer but none of their siblings that were not of that age or received the cow’s milkhave cancer is of concern to me.

Are their other examples out there?

44

I have tried to obtain more information about the study since that time and havenot been very successful. Iowa state cancer registry finds an increase in thyroid can-cers from 1.7 cases per 100,000 in 1973 to 3.4 cases per 100,000 in 1995. The reg-istry states that many cancers have increased over this time and that this is mostlikely from early detection. My concern is that in this small example of my familynone of them were diagnosed or treated for the thyroid cancer in the geographicalarea in which they were exposed and only one of them was diagnosed and treatedin Iowa. Therefore, I am concerned that on a state basis it may be difficult to evalu-ate these statistics.

This brings me to my second reason for concern over this fallout issue. What doI tell my patients and my other family members regarding areas that have this in-creased radioactive fallout? Patients come to see their doctor to get answers and tounderstand what is happening to them. I don’t have enough information to tellthem. If they were living in these areas known to have a higher rate of radioactivefallout, what should they do? Should they have their thyroid examined? Should testsbe run? Should they have scans of their thyroid? It is difficult to be their adviserwhen I have so little information. It is known that external beam radiation whichwas given to young patients in the neck area for various reasons such as acne oran enlarged thymus have a higher incidence of thyroid cancer. Physicians use thispiece of information when evaluating patients. This is because these patients witha history of external beam radiation to the thyroid typically receive screening forthyroid cancer because of this higher incidence. On the other hand, as a physicianI have no idea whether this should be true for patients exposed in the higher areasof radiation fallout. We do know that the thyroid is a very radiation sensitive organand that I-131 does give off a relatively high radiation dose to the thyroid becauseof the thyroid’s ability to concentrate iodine. Because of the lack of informationabout the fallout, I don’t know whether I should be more suspicious when examiningtheir thyroid? Should I order additional imaging tests on these patients as I mostlikely would on patients exposed to external beam radiation? Should I follow themmore closely than a routine patient? I need for you to understand that this lack ofinformation makes me a less effective physician to my patients, and therefore, I amhere as an advocate for their health. I also worry about people who do not receiveroutine medical care. What should be done to evaluate these people.

I also know that I don’t want patients alarmed unnecessarily. In adults, the inci-dence of thyroid nodules is between 4 to 7 percent. This incidence tends to increasewith age and is greater in women. The vast majority of these nodules are benignin nature and need no further evaluation. I can appreciate the problems that couldbe created and the unnecessary procedures that might be performed if this situationis not handled properly.

In summary, this committee has the ability to give physicians and patients theinformation they need. What are the risks for people who were exposed to radio-active fallout? Do the risks differ depending on factors such as location, age, andingestion of cow’s milk? Has an increased incidence of thyroid cancers been studied?What is the best way for physicians to screen these patients if they are at higherrisk? Please do the necessary studies and disseminate the appropriate informationto physicians and patients so we can use our medical knowledge to continue to havea greater than 95 percent cure rate for thyroid cancer.

TESTS

Senator SPECTER. Thank you very much, Dr. McGuire.Dr. Lyon, your charge is a very serious one, that you would not

trust the NCI or the administration to carry out these tests. I ap-preciate the fact that you have had very extensive experience inthe field. Can you tell us why you would not, in effect, trust NCIhere?

Dr. LYON. Well, at least under the current administration, underthe constraints placed on by Federal contract——

Senator SPECTER. When you say ‘‘under the current administra-tion,’’ could you be specific?

Dr. LYON. Well, I say the current siting of radiation studies atNCI.

Senator SPECTER. Are you talking about Dr. Klausner?

45

Dr. LYON. No, Dr. Wachholz’s group, who has the radiation stud-ies responsibility.

Senator SPECTER. Why do you say that about that group?Dr. LYON. Well, because of the long past history on the earlier

Utah study, where we had the continued, continued problems thatI’ve detailed in my testimony.

Senator SPECTER. Dr. Klausner, are they here today?Dr. KLAUSNER. Yes.Senator SPECTER. Go ahead, Dr. Lyon.Dr. LYON. The other big concern is that there is no commitment

to any kind of public involvement in terms of citizens advisory com-mittees, informing the public of the results. I have been beat up,beat up verbally, in meetings with physicians and southwesternUtah on inconclusive results. I have had videotapes played to meby various interviews given by officials in the Federal Governmentsaying it’s inconclusive, there is no effect. This is an area where weknow we have got people with radiation exposure of over 400 radsto their thyroid. The physicians have never been informed of that,and they have been told that the findings are inconclusive and thatthere is no cause for concern.

There was no effort to create any kind of a public group, anykind of a medical group that could even look at that. There has cer-tainly been no medical surveillance within the area, and there wasno willingness on the part of the NCI to even consider those kindof public health-oriented programs.

For this reason, I think continued work without heavy public in-volvement is simply going to be fruitless.

Senator SPECTER. Dr. Klausner, we will give both you and the in-dividuals who have been identified by Dr. Lyon a chance to re-spond. Dr. Lyon’s written statement is very forceful. It says: ‘‘I wasappalled to find that employees of one of the premier research in-stitutions in the world, the National Cancer Institute, in August of1997, just a month ago, were using the same tactics that had beenused for the last 40 years by officials of other Federal agencies.And even more upsetting to me was that these tactics had beenused to obfuscate their own research findings of potential excessesof thyroid cancer for many citizens of the United States.’’

He also complains about the delay in releasing the findings, andthen at page 11 he says: ‘‘Use of the term ‘inconclusive’ to describeour thyroid study is disingenuous. We found a threefold increasedrisk between childhood exposure to radioactive iodine and subse-quent thyroid neoplasms, with a clear dose relationship. Certainlyno researcher would consider exposing a group of children to radio-active iodine based on such a finding.’’

Dr. Klausner, how do you respond to that specific scientific find-ing of a threefold increase and his statement that he thinks it isdisingenuous? Pretty tough criticism.

Dr. KLAUSNER. Yes, it is, although it surprises me because wehave stated their finding, and just simply quoting their publication,that they showed a 3.4-fold increase. It represents, as they said, adifference of between 0 and 8 thyroid cancers and, as they said, be-cause the range was between 0 and 8, the standard scientific andmedical response to that is that there is some uncertainty aboutwhat the actual rate is.

46

But we said that the point estimate, as they pointed out and Ihave quoted them, was a 3.4-fold increase. We are not trying—I amnot sure why there is a perception that we are trying to downplaythis.

I must say I highly agree with Mr. Connor, that we need to moveto make sure that these sorts of studies—and we have been doingthat—have public oversight. What I have tried to do as the new di-rector of the NCI is, as I learned about this study, to move to com-pletely disclose it, to disclose all the information, make it accessibleto everyone.

We have a very extensive communications dissemination planwith the CDC. We are developing a new memorandum of under-standing with the CDC for all of our radiation studies. I thinkthese points are very well taken, but I am not sure what I can doabout the past other than work very hard to try to fix these things,and that is what we have done.

Senator SPECTER. Before we turn to Senator Harkin, I will giveyou a chance to respond, Dr. Lyon.

Dr. LYON. I just want to make one quick comment, that one ofthe concerns was we had inconclusive findings. We recognized that.Any rational researcher asks for additional years of followup, be-cause these people were just coming into their period of highestrisk.

The games that were played with our grant application were ap-palling.

Senator SPECTER. What do you mean, ‘‘games that were played,’’Dr. Lyon?

Dr. LYON. Essentially, after getting the grant funded, someonewent to the Board of Scientific Counselors, shares information withthem not in the grant application, and the grant is put on hold. Wewere never given a response, opportunity to respond. The grant isthen bounced around from institute to institute until finally it dies.

We have requested on separate occasions through our congres-sional delegation some effort to try to get funding for it, and themessage comes back: This is of no scientific interest, it has verylow priority within the HHS structure.

It bothers me that when you have an inconclusive finding, youknow it is inconclusive and have a way to fix it, and it is the impor-tant public health question that it is simply buried within the bu-reaucracy of the HHS and you are told that it is of limited sci-entific interest to the citizens of the United States.

Senator SPECTER. What about that, Dr. Klausner?Dr. KLAUSNER. I just completely disagree. We have been ask-

ing—I have been asking about, should we not do a followup onthis? The process by which grants come in, is that they do not comein to the Institute. They come in to the NIH, they go to the Divi-sion of Research Grants.

The Division of Research Grants actually, as I understand, sentthat to NIDDK. You were puzzled about that, but that Institute isthe Institute that oversees thyroid studies.

Dr. LYON. It actually went to NIEHS, then was bounced toNIDDK.

Dr. KLAUSNER. I am sure these are complicated processes and Iam happy to look into it.

47

Senator SPECTER. Dr. Klausner, are you aware of the specificsDr. Lyon is talking about?

Dr. KLAUSNER. No, sir; I am not aware of the specifics.Senator SPECTER. I am just interested in what the facts are.Dr. KLAUSNER. I am not aware of the specific allegation that

someone interposed and interfered with the process of peer reviewor of granting. But it is not true that we are not interested in fund-ing followup to this. In fact, I must say we have been discussingnumerous times over the last several months how interested weare in the opportunity to follow up the Utah cohort study.

Senator SPECTER. Well, would you provide the subcommitteewith those specifics?

[The information follows:]

FUNDING RESEARCH PROJECTS

During the October 1 hearing regarding the report of the National Cancer Insti-tute (NCI) on exposure of Americans to radioactive fallout from the Nevada TestSite, Dr. Joseph L. Lyon (University of Utah) alleged that Dr. Bruce Wachholz(Chief, NCI’s Radiation Effects Branch) intervened in some way to influence the de-cision not to fund Dr. Lyon’s research grant application on thyroid disease resultingfrom exposure to radioiodines. These same allegations were made in a recent articlethat appeared in Nature. These are very serious charges.

The application referred to by Dr. Lyon was titled, ‘‘A Cohort Study of ThyroidDisease from Radioiodines.’’ The original application was submitted to NIH in 1987and assigned to the National Institute of Environmental Health Sciences (NIEHS).It was reviewed by the Epidemiology and Disease Control Study Section (Sub-committee 2) in February/March 1988. The application received a priority score out-side the funding range for NIEHS that year, so Dr. Lyon revised the application andresubmitted it, this time receiving a priority score within a fundable range. How-ever, the application was given a ‘‘Council Deferral’’ at the February 1989 NIEHScouncil meeting so that further information could be gathered.

At issue was the high cost of the study; whether other studies addressed the re-search question; and maintaining program balance within the NIEHS grant port-folio. As is done in the normal course of determining whether scientific overlap ex-ists between two projects, NIEHS staff contacted Dr. Wachholz, who was the projectofficer on an NCI research contract to Dr. Lyon at that time, to determine if therewas any scientific overlap between the NCI contract and Dr. Lyon’s most recentgrant application. Dr. Wachholz provided the necessary information about the workscope of the NCI contract, in a manner that is recalled by NIEHS staff as havingbeen both thorough and objective.

NIEHS made the evaluation as to whether there was scientific overlap betweenthe ongoing contract and the grant application. Subsequently, it was decided by theDirector, NIEHS, not to fund the application. Dr. Lyon later submitted a revised ap-plication on the same topic which did not receive a fundable score. However, Dr.Lyon did have a grant funded by NIEHS during this time period entitled, ‘‘RadonProgeny and Risk of Lung Cancer.’’ The project period for this grant was from Sep-tember 1, 1988 to August 31, 1995.

FOLLOWUP STUDIES NOT MADE

Senator SPECTER. Senator Harkin.Senator HARKIN. Thank you, Mr. Chairman, and I appreciate

your line of questioning. I think it kind of gets to the heart of this.That is, we need to understand the past and why this informationdid not get out and why followup studies were not done. But Ithink to cut through it now and start looking at it and get the fol-lowup studies done as soon as possible—but there are people outthere who are now in their forties, fifties, sixties, and if you aregoing to study it for another 20 years, we do not have that time.

So it seems to me that we have a lot of information already onwhich we can make rational, informed decisions on information to

48

practitioners and to public health agencies and to the citizenry atlarge as to what they ought to do. I do not know why we cannotcut through this and get this job done.

What I hope we can do here, Mr. Chairman, is to consider howwe bring together NIH or NCI as a part of NIH, the Centers forDisease Control and Prevention, and the U.S. Public Health Serv-ice in a working group to decide what basis do we have to go onfrom the studies we have done. We have done a lot of studies. Andwhat can we do to take that information and get it out as soon aspossible.

I have been informed, Dr. Klausner—I noticed this over the lastfew months—that the increase in the use of Synthroid in this coun-try has just skyrocketed in the last 10 to 15 years. Why is that?Why are so many hundreds of thousands of people now takingSynthroid?

Can I just throw that out and ask for one of you doctors or some-one to respond to that? Do we know? Anybody?

[No response.]Senator HARKIN. I feel like that guy in ‘‘Ferris Buehler’s Day

Off’’: Anybody?Dr. BEYEA. I think it is premature to leap to conclusions as to

what the cause is, but I do know this, that we explored the possi-bility of talking to the manufacturers and giving us the statisticson the increase in sales by county. I could not afford to do it, butit could be done. One could get those statistics for every county inthe United States, match them up, correlate the increase in thatdrug, and it is a very useful thing to do.

Senator HARKIN. Why does a doctor prescribe Synthroid to a pa-tient?

Dr. KLAUSNER. Overwhelmingly, the reason that a doctor pre-scribes Synthroid is to treat hypothyroidism. Now, there are manydifferent ways in which people assess whether someone is hypo-thyroid. One of the issues and controversies is the definition ofwhen a person is hypothyroid or slightly hypothyroid and whenthey might benefit clinically from thyroid replacement.

Senator HARKIN. And would they also prescribe Synthroid if, ongiving an exam, they felt nodules?

Dr. KLAUSNER. No; they should certainly not do that.Senator HARKIN. That is what was prescribed for me by a doctor.Dr. MCGUIRE. It depends.Senator HARKIN. Pardon?Dr. MCGUIRE. There are people with goiters or nodular thyroids

that are put on Synthroid at times.I have one question. When he was talking about——Senator HARKIN. I do not understand this. I have been taking

Synthroid for 17 years and I have been taking it because I hadnodules on my thyroid, and I have more nodules on my thyroid.And I am just wondering why. You all say no, doctors would notdo it.

Dr. KLAUSNER. Not automatically. That is often a correct thingto do. What happens is the Synthroid is given and that reduces thestimulus that is released from the brain for your thyroid to grow.So the idea is that then that would reduce the possibility of thenodules.

49

Senator HARKIN. It is possible that doctors are prescribingSynthroid because they feel nodules on a thyroid?

Dr. KLAUSNER. Absolutely.Senator HARKIN. Thank you.Dr. BEYEA. They also may prescribe it because they are seeing

an increase in hypothyroidism. They also may be seeing that aswell.

Senator HARKIN. That is true.Well, again, the reason for that line of questioning for me is that

chart that you held up, you Dr. Beyea, that shows that perhapsthere is more happening out there than just cancer. Why are somany people taking Synthroid? They did not 20 years ago, they didnot before that. But now all of a sudden it has skyrocketed.

Dr. MCGUIRE. Senator, if I may. They were talking about a coun-ty, looking into where Synthroid was or looking into more thyroidcancers in different areas. One concern I have is that in Iowa therehas been an increased incidence of thyroid cancer and that mayhave been caused by many things, one of them possibly this. Butof my relatives, the Iowa registry would have only known of oneof them, because only one of them was still living in Iowa, and thenin a different part of Iowa, when she was diagnosed.

Senator HARKIN. See, that is a problem.Dr. MCGUIRE. So I am not sure State registries are going to be

very helpful in this area.Senator HARKIN. That is true. From my own personal case, some-

one living in Pennsylvania getting thyroid cancer who grew up ona farm in Iowa.

Dr. MCGUIRE. Exactly.Senator HARKIN. How do you know?Dr. MCGUIRE. Exactly.Senator SPECTER. Senator Harkin, let me just make an interjec-

tion and I will yield back in just a minute. I am going to have toexcuse myself for this next session, but we will be following up. Weare going to yield to Senator Craig in a few moments, who may beable to stay longer. Of course, he has not had his round yet.

But we are going to pursue these matters. This subcommittee isgoing to pursue the details as to what Dr. Lyon has said as to whathas happened on the NIH grant application. We want to get veryspecific and know exactly what happened and who is right and whois wrong. This ought to be subject to our determination, becausethese are very serious charges about this administration of NCIbeing unable or—let me use a moderate word—inappropriate or notup to doing this job, considering the $2.3 billion which we are ap-propriating again, plus, for NCI.

We will go into the details as to what has been testified aboutthe cover-up in the past. As a result of what we see here, we mayschedule additional hearings of the subcommittee.

Senator Harkin, I yield back to you. At your conclusion, SenatorCraig, if you would proceed to chair the hearing. Thank you.

Senator HARKIN. I appreciate that very much, Mr. Chairman. Ithink we may have to have some follow-up hearings on this.

Let me just again, Dr. Klausner, if I might ask: In terms of pub-lic involvement, since we are on that topic right now, there is cur-rently in place some mechanism to ensure public accountability in

50

health studies. Dr. Klausner, did the study research team havecontact with the HHS Advisory Committee on Energy-Related Epi-demiological Studies, often referred to as ACERS?

Dr. KLAUSNER. I think this is the committee that—I am not surewhat the exact interactions were between that committee. Is thisthe committee, Mr. Connor, that you are on?

Mr. CONNOR. Yes; here is your letter.Dr. KLAUSNER. So in 1996 I received a letter from Mr. Connor

asking about the overall activities of the NCI in radiation-relatedstudies. And this was transferred to the staff, the appropriate staff,to respond. What happened, and this was a problem, there weretwo, at least two, different groups in two different divisions of theNCI that were doing these studies. This was sent to one divisionand a collection, a description of studies were sent, but it did notinclude this study because it was in a different division. That wasa slip-up.

That was recognized later and then the information about thisstudy was transferred, as I understand.

There was, I gather, appended to this letter a resolution that thecommittee had agreed upon in April of 1996, if I have this right,to gather more information about the I-131 study. That appendedresolution was not referred to in the letter, and again it was anoversight. When the individuals involved in the study received aninvitation to speak to this committee, that was arranged, and theywill be doing that at the next meeting.

Senator HARKIN. Let me understand. My staff tells me we havetwo members of the committee here. Are you a member of thatcommittee, Dr. Connor? ACERS, it is called?

Mr. CONNOR. Yes.Dr. LYON. And I, too, am.Senator HARKIN. I did not know who they were. Advisory Com-

mittee on Epidemiological Radiation Studies, referred to asACERS. My staff tells me that this HHS-chartered body was estab-lished as a step to ensure oneness and to help coordinate betweenvarious research teams.

Again, I just want to know, did the study research team have—I will ask you the same question. I am trying to get through it. Didthey have contact with this group, ACERS?

Mr. CONNOR. There is one letter that exists between Mr.Wachholz and Jim Smith, the head of radiation studies at CDC. Itis a several-page letter and that is the contact, and it is just veryunfortunate.

Senator HARKIN. When was ACERS set up? What year was it?Mr. CONNOR. ACERS was set up—in my testimony I mentioned

the 1990 memorandum of understanding between DOE and HHS.That memorandum of understanding calls for the creation of thatadvisory committee, which is supposed to oversee the Center forEnvironmental Health’s activities and NIOSH’s activities, to focuson Department of Energy facilities and DOE releases.

So obviously one of the concerns of our committees was, here wasa major DOE release and a study about these releases that we didnot have access to. There was great concern on the committee fromDr. Lyon and others that the study was being suppressed, that the

51

American people were not being told the magnitude of the dosesthat the researchers were finding in that study.

We were very concerned about that. That was one of the reasons,not the only reason, but one of the reasons, we began to make over-tures to NCI to have a dialog and eventually get this material outto the American people.

Senator HARKIN. Dr. Klausner, does NCI consider itself underthe jurisdiction of ACERS?

Dr. KLAUSNER. I am told that this was not, this study was notconsidered under the jurisdiction of ACERS. I have since had dis-cussions with Dick Jackson and Henry Falk from the CDC so thatwe can establish a memorandum of understanding, which we aredoing now, so that we can completely share all the information ofall the activities that the NCI is engaged in related to radiation.

But my understanding is that this particular study was inter-preted as not under the purview of ACERS.

Senator HARKIN. I am sorry to belabor this so long. I just do notunderstand why. I mean, it concerns the public health. It concernsthe very reason why it was established, and that is to get informa-tion out to the public when we have these health studies. I do notunderstand that. I just do not, and I do not know what we haveto do to make sure this does not happen again.

Dr. KLAUSNER. Well, this is what we are moving on. For a lot ofthis, I am in the position of——

Senator HARKIN. Who would have made that decision, Dr.Klausner, that NCI and this report was not under ACERS, thatstudy?

Dr. KLAUSNER. Well, when I have spoken to the people at CDC,they tell me that they did not expect that this study would comeunder that jurisdiction, that the original memorandum of under-standing covered the studies that were being moved from the DOEto the CDC, and the agreement as part of that movement was thatthere would be an oversight.

So in the original charter, in the original memorandum of under-standing, there was not the expectation. As I have queried theCDC officials to find out, well, where did this fall through thecracks, they said their expectation was that this was not under thepurview of ACERS. Now, ACERS in this letter asks for informationabout that, and I think that is quite reasonable and that is whyI have now moved to develop a separate memorandum of under-standing between the CDC and NCI.

Senator HARKIN. So you say the basic responsibility lies with—if CDC had said yes, this should be under ACERS, that would havemade all the difference in the world? Is that what you are saying?

Dr. KLAUSNER. Well, I assume that then that would have beenbrought to the NCI at the time as their interpretation of whatshould come under ACERS. That is the only thing I can surmisefrom trying to understand the past history.

Senator HARKIN. Do you have any observations on this, Dr.Lyon? You are a member of that committee.

Dr. LYON. My observations are more of an outsider, but the sensewas when this memo was put in place that there were still otherentities in the Federal Government that were pursuing their owninterests in radiation research. I think particularly the Russian

52

studies were viewed as an NCI preserve and did not come underthis, and that some of the residual studies, such as this thyroidstudy, were pretty well considered.

So there was very little effort made to try to even bring themunder. We finally asked for a briefing on the matter.

Dr. KLAUSNER. Right.Senator HARKIN. One last thing. Do you believe that we should

encourage you to move ahead, Dr. Klausner, in studying the othertwo areas that Dr. Beyea spoke about? And that is the nodularitiesand the autoimmune thyroid diseases that have not been covered.

Dr. KLAUSNER. I think the NIH ought to consider that. As Dr.Beyea I think has pointed out, not all of this is under the expertiseof the NCI, and I think that would be a problem. I think it is oneof the reasons to try to move us to a new page where this is verypublic, and why we have asked for a rapid response from the IOM,so we can get a public hearing about where we stand now, whatstudies are going to need to be done, and, very importantly, to an-swer Dr. McGuire’s most important concern: What information dowe give, the ‘‘we’’ being the entire community, to health physicians,families, patients, communities, public health officials, to answerthe questions? Not that we are going to have a perfect and defini-tive answer to everything, but the answers; as much as we can, wehave the information there and it is available to everyone.

I think that is the most important thing and that is what we aretrying to do.

Dr. MCGUIRE. Senator, right now, I went to the Internet to tryto get some information on this and called the 800 number for theNCI, and I was told basically that there was no problem, but if youwere concerned you could go to your doctor. So that is not what Iam hearing here, so we definitely need to get some information out.

Senator HARKIN [reading]:Even then, the number of children and grandchildren with cancer in their bones,

with leukemia in their blood, or with poison in their lungs might seem statisticallysmall to some in comparison with natural health hazards. But this is not a naturalhealth hazard and it is not a statistical issue. The loss of even one human life orthe malformation of even one baby who may be born long after we are all goneshould be of concern to us all. Our children and grandchildren are not really statis-tics toward which we can be indifferent.

That is from President John F. Kennedy’s speech on ending theabove-ground tests in 1963.

Senator CRAIG [presiding]. Senator, thank you.Let me turn to Senator Gorton, who has just come in and needs

to be off to another committee. Senator.

REMARKS OF SENATOR GORTON

Senator GORTON. Thank you. I simply wanted to welcome myconstituent Mr. Connor here and say I am sorry. We are at thevery end of coming up with the Interior appropriations conferencereport, but I have got to get back to that. But I have read his testi-mony. I am obviously very much aware of the concerns of thedownwinders all over eastern Washington.

I think the presentation he has made is a thoughtful one and therecommendations he has made are recommendations in the alter-native, at least, one or the other ought to be adopted. I thank him

53

for coming and sharing his experience and wisdom with the com-mittee here today.

Thank you, Senator Craig.Senator CRAIG. Senator Gorton, thank you.Questions of you, Dr. Klausner, and Dr. Lyon, and any of the

rest of you who would wish to comment. You have heard the chair-man and the ranking member speak of the frustrations that I thinkall of this committee shares as to the flow of information or thelack of flow or the unwillingness to provide factual information orin some instances the allegations of varying information.

As this information emerged in August, I mentioned in my open-ing comments that four counties in my State appear at this mo-ment to have experienced elevated levels of fallout. Under someweather scenarios, we are termed downwind of Nevada, and ofcourse Nevada is a bordering State.

Based on the current situation, the current knowledge, lack ofknowledge, coverup of knowledge, the failure to disseminate and-or interpret, whatever it is we are trying to understand here—andI am not sure what it is yet—what do I tell the citizens of thosefour counties, Dr. Klausner, at this moment? What should theyknow? What should they expect to know in the future?

Dr. KLAUSNER. I think the citizens should know that they wereexposed. They should know how to understand who was exposedand try to—it depends on how old you were. What is most impor-tant in the individuals who were exposed is children.

I think the public health officials need to know. We have dis-cussed with the public health officials of your State about gettinginformation and disseminating information about thyroid cancer,about thyroid exams, about this study. We have been working withthem. We will continue to work with them. We have asked themwhat their plans are in terms of monitoring and public health ac-tivities in all of the most heavily exposed States.

As I said, there is and will continue to be—and this is very im-portant—a tremendous amount of information and press coverageand awareness about this, to reawaken awareness that has sort ofcome and gone about radiation, to emphasize that to those areas.And those individuals should consult with their physicians.

Our recommendation now, along with the American Thyroid As-sociation, is that individuals who were exposed—and they can findout their exposures by looking at those maps and knowing whattheir ages were—should see their physicians, talk to their physi-cians, and what we recommend is a manual thyroid exam. Thoseremain, I think, the most reasonable interim recommendationsuntil we get as rapidly as possible a set of broader national rec-ommendations as to whether there are other recommendations interms of public health or medical intervention or surveillance fromthe Institute of Medicine study.

Senator CRAIG. Dr. Lyon.Dr. LYON. I would agree with Dr. Klausner. I think that is a very

responsible recommendation at this point in time. I do want to addone very brief comment that I hate to bring up, but one of theissues here is how is this going to be investigated from a publichealth standpoint, what specific types of scientific studies.

54

Again going back into the earlier era, part of our fallout studyin the 1980’s included a case control study to examine the risk ofthyroid cancer in northern Utah that would have been, we thoughtfrom the contamination, well outside the southwestern corner ofthe State. We were well into the study, developed the methodology,had not yet begun collecting cases, and we were given a Hobson’schoice on our funding, which was basically you can do the cohortdown in southwestern Utah or you can have the case control. Wechose the cohort.

I think in hindsight it is unfortunate, because that would haveprovided a methodology well worked out that could be applied tothe rest of the United States. We probably can resurrect some ofthat material from our files and we had actually gotten to the pointof writing a questionnaire and defining exposures, and this may behelpful in terms of getting fairly quick answers for what risk, whatthe actual risk may be, at least on a State by State basis.

Senator CRAIG. Dr. Connor.Mr. CONNOR. Senator Craig, one of the things about the study

that is most disturbing to me is that it was apparent that, muchearlier than the past year, the researchers had the capacity toknow where the highest risk people were. If I can read from—thisis a paper that Mr. Wachholz wrote for the Journal of Health Phys-ics in 1990 that was apparently based on an earlier presentationat a conference: ‘‘Completion of the exposure and dosimetric seg-ments of the study is anticipated in 1990–91.’’ Which indicates tome that, much earlier than the past year or two, that they havethe capacity in-house and the understanding in-house, or shouldhave had the understanding, to know where the people at highestrisk were.

Why did they not contact public health officials and engage in animmediate dialog to find out how they were going to contact thosepeople and their physicians, if only the advice was, check with yourphysician on this at your next doctor’s visit, have your thyroid ex-amined? Those things were very basic things that could have hap-pened, that could have made a difference in people’s lives, perhapshave prevented longer illnesses or deaths. And it did not happen.

I would encourage you to look at this to find out what in the pro-tocol of NIH, NCI, prevented them from acting at that threshold.Again, at some point this ceased being a scientific study, whenthere was evidence to indicate that people were at substantial riskand that we had the means to locate them, perhaps not locate themdirectly in those counties, but knowing that they were in thoseareas at the time of the exposure.

We have known who the vulnerable folks are. It is small childrenand particularly the females that were at the highest risk. Whywere they not notified and why were they not given a chance to domore for their health?

Senator CRAIG. Does anyone else wish to comment on that? Dr.Beyea?

Dr. BEYEA. I would just like to make one or two points. First ofall, I do not want to—I hope the impression is not gotten acrosshere that we have to do more scientific studies before we will knowwhat kind of recommendations to make to medical health provid-ers. There is a great deal of information already available that can

55

do that. It may be that later studies will help refine those rec-ommendations, but we do not have to wait for that.

The other thing: I think you have a very difficult time, Senator,in telling your constituents as to what they should do. It seems tome I would feel in a very difficult position if I were in your place,because the Government could have done something a long, longtime ago. They could have issued advisories in the fifties and thesixties. They could have had people not take fresh milk. They couldhave had farmers not feed fresh food.

So I think that some apology is in order perhaps to the Americanpublic for what has gone on during that cold war period. We haveto recognize that it was different times, different concerns. Butthere are still some things that were done that we probably will beashamed of.

Senator CRAIG. Let me conclude with this, because the AmericanThyroid Association has been mentioned. I am reading from a copyoff their web page, and this is a press release, ‘‘Radiation exposurefrom past Nevada atomic bomb tests.’’ The second paragraph: ‘‘Ra-dioactive iodine has been used for more than 50 years in almost 10million individuals as part of routine thyroid function tests inamounts far greater than that delivered by fallout and careful long-term follow-up studies of these individuals have not shown any evi-dence of excess thyroid cancer attributed to radiation exposure.’’

Senator CRAIG. Is that inconsistent with what we are now or anyof you are saying?

Dr. BEYEA. No, because you have to make a distinction betweenadults and children.

Senator CRAIG. And therein lies the difference?Dr. BEYEA. There lies the major difference. Now, you have to rec-

ognize that the ratios are enormously different. As an adult yourrisks are way, way down, maybe a factor of 10 times lower, thanif you are a child.

Plus I do not think the American Thyroid Association in thiscountry is the last word on thyroid health effects. They after all,they are good doctors, they do good things. They do not want, Ithink——

Senator CRAIG. The problem is the public might view them as thelast word. They pack an official title.

Dr. BEYEA. That is right. But we have the various NationalAcademy reports that are put out periodically. It is a problem thatradiologists, particularly in this country, have a mind set thatradioiodine is good for you, and in many cases it is good for you.If you have hyperthyroidism, radioiodine may be very helpful toyou.

But we can make that a choice. We do not have to have individ-uals be given that against their will.

Dr. MCGUIRE. Senator, typically as a physician, typically thefamily physician or internal medicine doctor is going to be the firstperson who is going to see a patient with a nodule, and I am notsure they are reading the American Thyroid Association’s webpage. So I think you are exactly right, that information needs togo through different channels.

Senator CRAIG. Thank you.Senator, do you have any further questions?

56

Senator HARKIN. Senator, just a couple.Senator CRAIG. I will let you follow up and conclude and adjourn

the hearing, if you would.Senator HARKIN. I appreciate that, and I will very shortly, be-

cause I know staff has to get over to the conference committee, andso do I.

I do have a question that Senator Daschle wanted asked. He hasan intense interest in this, has expressed it to me personally, andhe had a written question, which basically—I will just read a sum-mary of it. He says:

On July 27 I contacted you, Dr. Klausner, with four straightforward requests, allof them directed toward providing the public with the answers it was promisedyears ago and assuring that future public mandates will be handled with more ac-countability, responsiveness, and basic respect for the very real concerns of peopleexposed to the iodine-131 fallout.

Specifically, I asked you to assess and report to the Congress about the apparentdelays surrounding the study

That is what we are talking about now——Take whatever steps are necessary to ensure that similar delays do not under-

mine future NCI projects, establish a date certain for the Institute of Medicine’sevaluation of the appropriate medical response to the various exposure levels associ-ated with the fallout, and to evaluate whether there was a significant change in theincidence of thyroid cancer in the wake of the nuclear testing, particularly in hotspot areas.

Basically, he says: ‘‘To my knowledge, you have not made appre-ciable progress toward fulfilling any of these requests.’’ I believesome of that has been done here today, but would you please re-spond to Senator Daschle’s questions that he wrote on July the 27.I will make that a part of the record.

[The information follows:]

LETTER FROM RICHARD D. KLAUSNER, M.D.

DEPARTMENT OF HEALTH AND HUMAN SERVICES,NATIONAL INSTITUTES OF HEALTH,

Bethesda, MD, September, 30, 1997.Hon. THOMAS DASCHLE,U.S. Senate,Washington, DC.

DEAR SENATOR DASCHLE: Thank you for your letters to Secretary Shalala and tome pertaining to the release of the National Cancer Institute (NCI) study on theiodine-131 fallout from atmospheric nuclear weapons tests at the Nevada Test Sitein the 1950’s and early 1960’s. I hope the following information is helpful.

We at NCI share your concern that the information available in this report bemade available to the public as soon as possible. Our objective has been to providethe report in its entirety (several hundred pages of descriptive text and mathemati-cal models, and over 100,000 pages of data and results) no later than October 1,1997. While these technical arrangements are being completed, estimated averagethyroid doses of I-131 in every county of the 48 contiguous states were released onAugust 1 in an ‘‘Interim Final’’ form on the NCI’s World Wide Web site (http://rex.nci.nih.gov; or http://nci.nih.gov) in the ‘‘What’s New’’ link.

The data and mathematical modeling contained in the full report were essentialto reaching the national average estimated dose. They will also serve as tools forpublic health officials and researchers to use to determine exposures and to developindividual dose estimates. In fact, it is widely known that fallout from atmosphericweapons tests was indeed carried nationwide and that Americans in the contiguous48 states at that time experienced some level of exposure. The fallout report itselfwas not intended to provide risk assessments of thyroid cancer from iodine-131.

Unfortunately, a determination of what, if any, health effects might result as aconsequence of I-131 exposure will require further research. Although it has beenwidely known for many years that radionuclides (including I-131) were deposited

57

across the United States following atmospheric nuclear bomb tests, what has neverbeen clear is the role these varying levels of fallout play in the development of can-cers, particularly among persons who might have been exposed as children. It washypothesized that if we knew the risk coefficient correlating thyroid cancer to I-131exposure and thyroid doses, and if we knew how to estimate how much fallout eachindividual had been exposed to, those population groups who might have been athighest risk for developing cancer could be determined. They could then be providedwith information needed to monitor their health. A preliminary review by NCI ofregions estimated to have higher overall exposures to I-131 shows no increased rateof thyroid cancer incidence or mortality in the 40 years since the Nevada Test Sitesbegan. Further followup is underway, and our statistical and registry experts haveprovided advice to state health departments interested in pursuing their own analy-ses.

With the passage of Public Law 97–414, NCI was asked to develop methodologiesto assess the amount of I-131 from fallout to which the American people were ex-posed; to estimate the radiation dose to the thyroid from the exposures; and to as-sess the risk of thyroid cancer from this exposure. We have completed two of thethree tasks—we have successfully developed mathematical models using data andcalculations from many Federal and private sources. The human I-131 exposuredata and the few health consequences observed thus far among exposed populationsstudied have not been adequate to calculate thyroid cancer risk from these expo-sures. It had been anticipated that a follow-up study of persons living downwindfrom the Nevada Test Site would accomplish this; however, the results of that study,published in 1993, were suggestive but not conclusive with respect to thyroid cancer.The Chernobyl nuclear accident provides a tragic opportunity to obtain the very in-formation needed to make these risk estimates. These data together with those fromon-going epidemiologic studies in Hanford, Washington may be sufficient to providean estimate of cancer risk that can be applied to the estimated doses from I-131fallout from the Nevada Test Site.

The NCI and the Department of Health and Human Services (DHHS) of courserecognize that there are potential implications of the I-131 exposure study for thehealth of the American people. There was never any intention to conceal the results.In fact, the raw data and preliminary formulae have been made available upon re-quest during this period of preparation and refinement. In addition, the methodolo-gies used in the study and preliminary results have been presented at scientificmeetings and published in the scientific literature since 1990. Updates to the NCI’sBoard of Scientific Counselors were frequent and open to the public. Periodicprogress reports to Congress were drafted and forwarded to NIH for transmittal tothe Secretary, HHS. The Thyroid/Iodine-131 Assessment Committee was charteredin 1984 with experts in all the fields of science relevant to this study to advise theNCI staff on the conduct of this study. Meetings of the advisory committee wereopen meetings, and it served until 1993 as a place where presentations and discus-sions of the latest findings of the study and more broadly in the scientific arenacould be aired publicly.

As I mentioned earlier, the data available to link I-131 fallout to specific cancersare not conclusive. All currently available data relating to a statistically significantincreased risk of thyroid cancer are from external irradiation. Therefore, care mustbe taken to craft a public health message to increase awareness of possible healtheffects without creating alarm or undue harm. In the late 1970’s, NCI undertooka public health campaign to alert people to the possibility of developing medical ir-radiation-related thyroid cancer. The campaign was designed to: (1) brief physiciansabout how to examine, diagnose and treat irradiation-related thyroid tumors, and(2) to urge the special population in the United States that was at increased riskof developing thyroid cancer to be examined by a physician. Because there is no es-tablished risk coefficient for I-131 and thyroid dose exposure, the Department ofHealth and Human Services has requested that the Institute of Medicine (IOM) atthe National Academy of Sciences review the data to assess whether risks can bedetermined, and to develop recommendations for physicians on how to identify,evaluate, and treat persons who might be at risk of thyroid disease because of theexposures to radioactive iodine. The IOM estimates that its recommendations willbe available in June 1998.

The Department has pledged to pursue the establishment of a task force or work-ing group of appropriate Federal agencies to discuss and implement the next stepsin addressing the public health concerns. In the meantime, we are suggesting thatconcerned individuals consult with their physician during their next visit.

58

The NCI will be pleased to keep you informed as these matters evolve.Sincerely,

RICHARD D. KLAUSNER, M.D.,Director, National Cancer Institute.

LETTER FROM SENATOR TOM DASCHLE

U.S. SENATE,Washington, DC, August 27, 1997.

Hon. DONNA SHALALA,Secretary, Department of Health and Human Services,Washington, DC.

DEAR MADAM SECRETARY: Enclosed is a copy of my letter to Dr. Klausner reiterat-ing my concerns regarding NCI’s handling of its 1982 congressional mandate to as-sess the impact of iodine-131 fallout associated with open-air nuclear testing be-tween 1951 and 1962. I feel strongly that the Institute’s inadequate actions in theface of a potential threat to the health of thousands of individuals must be inves-tigated and explained, both to prevent the situation from repeating itself and todemonstrate the government’s fundamental accountability to the public it serves.Most importantly, NCI must fulfill an essential unmet requirement of its mandate:to provide insight and guidance on the long and short-term health implications ofthe nuclear testing.

I am requesting that you work closely with Dr. Klausner and the National CancerInstitute to ensure that the public’s interests are being served from here forward,and to identify and address any deficiencies that may account for the Institute’s de-layed and incomplete response to this serious problem.

Thank you for your attention to this matter. Feel free to contact me directly ifyou have questions.

Sincerely,TOM DASCHLE,

U.S. Senator.

LETTER FROM SENATOR TOM DASCHLE

U.S. SENATE,Washington, DC, August 27, 1997.

Hon. RICHARD KLAUSNER, M.D.,Director, National Cancer Institute,Bethesda, MD.

DEAR DR. KLAUSNER: As a follow-up to my inquiries over the past several months,I would like to reiterate my concerns regarding NCI’s handling of its congressionallymandated assessment of iodine-131 (I-131) fallout resulting from the 1950’s radi-ation tests in Nevada. The events leading up to and surrounding the release of theNational Cancer Institute’s (NCI) study of I-131 raise serious questions about NCI’scommitment to its statutory mandate to investigate, on a timely basis, the healthimpact of I-131 fallout.

As NCI’s July 25 press release states, ‘‘In 1982, Congress passed legislation call-ing for the Department of Health and Human Services to develop methods to esti-mate I-131 exposure, to assess I-131 exposure levels across the country from the Ne-vada tests, and to assess risks for thyroid cancer from these exposures.’’ Fifteenyears later, that public mandate is still unfilled. Fifteen years later—more than 40years after the initial tests—those exposed to the tests have virtually no informationabout the probable impact of the tests on their health or the steps they should betaking to protect their health. Given NCI’s proper emphasis on early detection ofcancer and other illnesses, this situation is especially troubling.

I am aware that the estimation process by which NCI calculated average radi-ation dosage required a significant amount of data. Nevertheless, that does not ac-count for the lack of any information on the progress of the study or any attemptto monitor the incidence of thyroid cancer in high exposure areas during the 15-yearinterim period. Neither does it justify NCI’s failure, even now, to meet the crucialrequirement of the 1982 mandate: to access and inform the public about the poten-tial health risks associated with the iodine-131 fallout.

The stakes are too high to allow this situation to be perpetrated, or to repeatitself. A delay in the delivery of crucial health information has the potential tomanifest itself in very real health consequences. In this case, potentially exposed

59

persons have neither the direct health information they need nor precautionaryhealth guidelines that could serve them in the absence of such direct information.Furthermore, inordinate delays such as those that have plagued this study have aserious corrosive effect on public confidence in the government’s commitment to pro-viding them with timely, objective scientific information and protecting their healthinterests.

I urge you to assess, and report to Congress about, the events surrounding thedelays associated with this study, take whatever steps are necessary to ensure thatsimilar delays do not undermine future NCI projects, and establish a date certainfor the Institute of Medicine’s evaluation of the appropriate medical response to thevarious exposure levels associated with the fallout. Finally, I ask that you evaluatewhether there was a significant change in the incidence of thyroid cancer in thewake of the nuclear testing, particularly in ‘‘hot spot’’ areas. If this information isreadily available, I ask that you share it with Congress and the public immediately.If it is not yet available, please estimate when it will be available and outline whatprecautionary steps should be taken in the meantime by those individuals who be-lieve they may have been exposed to potentially dangerous levels of radiation. Thepublic deserves a much clearer picture of the toll iodine-131 has taken on the Na-tion’s health.

Sincerely,TOM DASCHLE,

U.S. Senator.

ISOTOPE

Senator HARKIN [presiding]. The last couple of questions. We aretalking here about one isotope. Are there other isotopes out therethat we have to be concerned about? And if so, what are they?What do we know?

Dr. KLAUSNER. Overwhelmingly, I-131 is the major isotope re-leased, but there are other isotopes: strontium-89, strontium-90, ce-sium-137, barium-140, plutonium. And some of those in aggregatewere addressed by, I think, the important Utah leukemia study.These other isotopes are even more difficult to assess in terms ofexposures, et cetera, especially at this time.

The estimate that I have seen is that the amount of radioactivitythat individuals were exposed to for any of those isotopes weremuch, much less, significantly less, than I-131. That is why themajor concern has been about I-131.

However, we are interested in health effects of these other iso-topes. There are studies about them. They are very difficult stud-ies. They are very controversial results. And we look to see whetherthere are places where we can learn about the health and risk esti-mates from these other studies, such as surrounding the Mayacplant at the Techa River in the former Soviet Union.

There are estimates about strontium in particular, about itshealth effects. But as far as we can tell, the total exposures fromthese other radionuclides, as I said, are much, much lower to theAmerican people than was I-131. Others here may have more ex-pertise about this than I.

Senator HARKIN. Do we know about any other isotopes? Cesium,for example, I am told mimics calcium, so it is taken up in thebones and could lead to bone cancer. We have had increased inci-dence of bone cancer, we know, in certain areas.

Dr. LYON. We did very preliminary studies looking at osteogenicsarcomas, which would be assumed to have been—and tried to doit on a county by county basis. We found virtually no signal comingfrom it. We abandoned it because it really looked to be—the tumors

60

are extraordinarily rare, very, very difficult to study. So we backedoff on that.

In our thyroid dose estimations, we took into account other formsof iodine, so it becomes radioiodines. There are several other, butthey are much shorter-lived than iodine-131. 131 has a 8-day half-life. These have much shorter half-lives. But they were also in-cluded in our dose calculations.

To my knowledge, we have not looked at strontium or cesiumissues in any great detail.

Mr. CONNOR. The only comment I would like to make at thistime is that historically there was consideration of the total num-ber of estimated cancers that would be caused by strontium and ce-sium during the time of the weapons tests, and the numbers—thenumbers of excess cancer were fairly significant. That is one of thereasons that there was strong pressure for the test ban treaty.

So there has been consideration in the past and recognition thata number of cancers would be caused, distributed among the popu-lation. But what was never recognized to the extent was this milkpathway. Even though it was known privately, it was neverbrought out publicly that this was a major issue.

Senator HARKIN. Anything else on this specific thing, other iso-topes? I wanted to follow it up, and especially plutonium also. Plu-tonium is highly carcinogenic and, even though it may have beensmaller releases, it is much higher and much more carcinogenic.And its half-life is 24,000 years. So we still have a lot of this stufffloating around.

I am just wondering, of what concern should that be in terms ofthe amount of plutonium that was released in the atmosphere dur-ing all these tests?

STATEMENT OF ARJUN MAKHIJANI, COAUTHOR, ARTICLE, ‘‘BULLETINOF ATOMIC SCIENTISTS’’

Mr. CONNOR. Senator Harkin, Arjun Makhijani is here today andhe has done extensive research on isotopes and fallout. If youwould not mind, could I turn over the mike to him to have him pro-vide you with some information on this?

Senator HARKIN. I have a time constraint. That is my problem.Mr. CONNOR. We can provide the information for the record.Senator HARKIN. Bring him up here, yes. I am interested in this.Just state your name and everything for the record here. State

your name.Mr. MAKHIJANI. My name is Arjun Makhijani, Senator Harkin.My colleague Ben Franke actually is the dosimetric expert in our

shop, but since you called me. He actually compiled these numbersin a book we published with the ‘‘International Physicians for thePrevention of Nuclear War in 1991.’’

Senator HARKIN. Excuse me. Are you not the one that wrote thearticle for the ‘‘Bulletin of Atomic Scientists?’’

Mr. MAKHIJANI. I coauthored it. The principal author is backthere.

Senator HARKIN. I just wanted to make sure I knew who I wastalking to here. OK.

Mr. MAKHIJANI. These numbers are compiled from the UnitedNations Committee, Scientific Committee on the Effects of Atomic

61

Radiation, which calculated the doses from atmospheric testing andpublished them. This is the authoritative committee on the subjectglobally.

And if you take into account the testing from all countries—United States, Soviet Union, France, England, and so on, China—the cumulative global doses from radioiodine are estimated to beabout 2 percent of the total doses from all radioisotopes releasedin atmospheric testing. The main contributors to dose are—theseare integrated dose to the year 2000 from the beginning of test-ing—are carbon-14, cesium-137—in order; well, not quite in order;they are in different order in different years. But carbon-14, ce-sium-137, zirconium-95, strontium-90, ruthenium-106, tritium, ce-rium-144, iodine-131, plutonium-239, and then there are a numberof others.

Senator HARKIN. All of these are—really, I do not know the half-lives and stuff. But do we know any of the health effects of allthese?

Mr. MAKHIJANI. Yes, sir; I think quite a lot is known about thehealth effects of many of these isotopes.

Dr. BEYEA. Yes; we do know a great deal about the health effects,unfortunately, because of the A-bomb, the bombs that weredropped on Hiroshima and Nagasaki, 50 years of followup by theradiation health effects research. There is a huge body of literatureout there that tells us something about the health effects of radi-ation.

Of course we do not know everything, and that is why we needcontinued study of particularly some of these more obscure healtheffects that have not been as carefully studied.

Senator HARKIN. One last question. Why do you suppose it wasthat the Government of the United States saw fit to inform Kodakabout fallout and to give them advance warnings on where the hotspots would be, but would not do so for the general public, espe-cially in Utah and Idaho and places like that?

I am speculating here. Why would the Government not say:Look, we are going to have an atomic bomb blast; for the next cou-ple of months, people in this area, you ought not to drink milk.Why was that not done? I mean, they told Kodak to protect theirfilms.

Dr. LYON. I can comment, Senator, on one other inconsistencythat is even more interesting, and that is that the safety standardsfor the employees of the Federal Government working at the testsite were substantially different than for the general population.The example of that was the radiation monitor working in St.George on Shot Harry on May 19, 1953, when almost 80 percentof the exposure occurred, who spent the whole day out in the stuff,was told when he got back that evening, after he put a geigercounter on himself and found out he was clicking along at a prettygood rate, to burn his clothes, to shower off very thoroughly, by hissuperiors at the Atomic Energy Commission.

There was not one word said to the citizens that they could havedone exactly the same thing. I can only assume that there was con-cern about the safety issue shutting down the test site.

62

But it would have been a very simple, effective way, and I sus-pect if it had been done we would have found no excess leukemiadeaths in that county 20 years later.

Dr. BEYEA. Mr. Harkin, I would like to comment on that, becauseover the last few years I have been involved in looking at docu-ments, legal cases, discovery in legal cases, and have read docu-ment after document that suggests to me that there really needsto be a very important investigation, historical investigation ofwhat happened in this country in terms of radiation and radiationresearch.

From what I can tell, there basically has been a gentleman’sagreement for a long, long time to keep from the public what isknown, to channel research into certain circumstances, to makesure that an old boy network is always in charge of who is assign-ing research contracts. I say that as speculation. I say that basedon limited access to documents.

But it is a story that some day must be told. How was it thatso much about radiation was kept from the public for so long? Andin fact, it actually backfired, because had people been open fromthe very beginning I do not think we would have had the same sus-picion that we have today, and that is a certain irony.

But I hope that you and other Senators will look into these docu-ments that we see in the plutonium injection cases, we see in theOregon prisoners cases, where prisoners were irradiated and thenhad vasectomies. We see this in a number of cases. And we readthe documents where American officials kept things very, very se-cret and did not pursue scientifically the right answers.

I hope some day you will be able to help us find out the totaltruth.

Senator HARKIN. Well, I think this is the beginning of that proc-ess.

Dr. MCGUIRE. Senator, as a mother, I can only imagine what mymother-in-law feels like. She is a very educated woman and shewould never have done anything to hurt her children, and she feelslike she did it by giving them the cow’s milk. So I think it certainlywould have helped her if she had known.

Dr. BEYEA. Senator, I have just been passed a note that I thinkI should mention. I apparently have slandered the American Thy-roid Association inappropriately, and it is pointed out to me thatthe American Thyroid Association has recently been pushing forstockpiling of potassium iodide in connection with reactor acci-dents. So I do want to mention that everything about the associa-tion is not bad.

Senator HARKIN. Well, I think I have a lot of other questions, butI think the basic answer to them. But out of this I hope comes fol-low up at least—and we will, my staff and I am sure the committeestaff, will follow up on this to ensure that we put together, as Isaid, NIH, U.S. Public Health, Centers for Disease Control andPrevention, to get this information out to people. We have gotenough information now that at least people ought to be aware ofit. And I think there are certain guidelines that citizens can takeright now in terms of having checkups.

63

Beyond that, I am concerned about studies of other isotopes andwhat may be out there, again in the way of letting people knowwhat they ought to do right now.

I think there is another subset of what we are starting here, andthat is what was just mentioned by you, Dr. Beyea, and that is totry to find out, get some historical research here, and find out justwhat happened and why. Why did it happen that way—again, notas a way of self-flagellating ourselves as a country, but to sort ofset the stage for something in the future. In other words, let usmake sure we do not repeat these kind of things again in the fu-ture in this country. Enough suspicion and stuff out there of theFederal Government. We do not need this kind of thing happeningalong with it.

I am also concerned, following up, Dr. Lyon, with Senator Spec-ter on those grant proposals, and we will definitely follow up onthat.

PREPARED STATEMENTS

I ask unanimous consent to place in the record the statement ofthe other witnesses who were not able to come today, and otherstatements made by other Senators who were not able to be herethis morning also.

PREPARED STATEMENT OF SENATOR DIRK KEMPTHORNE

RADIATION EXPOSURE

I would like to thank Chairman Specter for holding this important hearing. To-day’s testimony represents an important step forward in our effort to get all of thefacts on the table.

The National Institutes of Health (NIH) has released the results of a nationwidestudy of radioactive fallout from above-ground nuclear tests conducted during the1950’s in Nevada. A large amount of cancer-causing Iodine-131 was released intothe atmosphere during these tests, raising many health concerns.

Much of the radiation from the tests traveled northward, falling over the Stateof Idaho. In fact, four out of the five most exposed counties in the entire countryare in Idaho. I find it appalling that only now are Idahoans discovering that theymay have been exposed to dangerous levels of iodine over forty years after it oc-curred. This is simply unacceptable.

It has been shown that children exposed to radiation can develop thyroid cancerlater in life. Idahoans exposed to radioactive fallout from these nuclear explosionsin the 1950’s may be at risk. If this is the case, the federal government must takeresponsibility for its actions. This responsibility includes compensation for victims.

I have sent letters to Secretaries Shalala and Pena calling on the Department ofHealth and Human Services to work with the Department of Energy and the NIHto further investigate this troubling disclosure to document all of the health impactsresulting from these tests. An aggressive examination dedicating all resources nec-essary is required to get to the bottom of this outrage. All options of remediationmust be examined. At present, I have received a letter from Secretary Pena pledgingto provide whatever data is necessary. I have also received an interim answer fromthe NIH. The NIH letter proposes a plan in which HHS will establish a task forceto ‘‘discuss and implement the next steps in addressing public health concerns.’’

I applaud the efforts of the NIH to continue to work to provide answers to Ameri-cans exposed during these tests. Nonetheless, the Federal Government must bemore responsive to the questions that I and many others have asked about this dis-turbing event.

PREPARED STATEMENT OF PETER G. CRANE

My name is Peter Crane, and I appreciate the opportunity to submit testimonyfor inclusion in the record of this hearing. The Subcommittee deserves the thanks

64

1 He wrote this letter on behalf of the American Thyroid Association, not in his official Govern-ment capacity.

of the American people for holding this hearing, and for bringing the attention ofthe public to the health effects of radioactive fallout on the thyroid glands of Ameri-cans. There can be little doubt that lives will be saved, and a great deal of humanmisery averted, because this hearing will have alerted the public and the medicalcommunity to be watchful for indications of radiation-caused thyroid illness.

The purpose of my testimony today is to discuss an issue closely related to thehealth effects of airborne radioactivity, and that is the prevention of such illnessesby means of the cheap and effective drug potassium iodide—‘‘KI,’’ in scientific short-hand. In submitting this statement, I am acting in my private capacity, as an inter-ested private citizen, not in my official capacity as Counsel for Special Projects atthe United States Nuclear Regulatory Commission.

My interest in this subject began when I developed thyroid cancer, at the age of26, undoubtedly because of x-ray treatments of my tonsils and adenoids when I wastwo. The disease recurred nine years ago, and then it took extensive radiation treat-ment—five hospitalizations over three years—to eradicate it. Illnesses of this kindaffect not just the patient, but the whole family, as my wife could testify. Our expe-rience, and that of other thyroid patients whom I know or have encountered, makesme believe that radiation-caused thyroid disease is worth preventing, if preventioncan be achieved easily and cheaply—as it can.

Americans tend to assume that the protection given our children is the most com-plete in the world. Where KI is concerned, this is not true. Countries all over theworld stockpile the drug, in accordance with World Health Organization guidanceand International Basic Safety Standards that the U.S. claims to support. The U.S.does not. And because the Government has kept very quiet on the subject of KI,comparatively few Americans realize that their children are not as well protectedagainst radiation from nuclear accidents as children in France, Germany, Slovakia,Sweden, Canada, Japan, Switzerland, Poland, and a host of other countries.

Stockpiling of KI was a major recommendation of the Kemeny Commission, whichinvestigated the accident at Three Mile Island for President Carter in 1979. TheGovernment promised to implement that recommendation but later reneged.

In 1986, during the Chernobyl disaster, the Poles drew on their stockpiles of po-tassium iodide, gave out 18 million doses, and successfully protected their children.Side effects were minimal. In the former Soviet Union, however, KI stockpiling anddistribution were haphazard. We are now seeing the tragic consequences: an up-surge of aggressive childhood thyroid cancer in children, frequently with spread tothe lymph nodes, which means extensive surgery. The photographs of the young pa-tients show incisions stretching from ear to ear. The number of reported casespassed the 1,000 mark sometime in 1996.

First and foremost, this is a medical issue, but I am not a doctor and do not pre-tend to be. What do the doctors say about potassium iodide? The American ThyroidAssociation voted unanimously last year to urge the Government to stockpile KI fornuclear accidents. It has made that recommendation for years, and its reasons arecompelling. Here is a July 8, 1996, letter from Dr. Jacob Robbins, a world-famousthyroid cancer specialist with the National Institutes of Health.1 Describing KIstockpiling as ‘‘long overdue,’’ he explained:

‘‘1. The Chernobyl experience has shown us that thyroid cancer is indeed a majorresult of a large reactor accident, even when evacuation is carried out;

2. The Polish experience has shown us that large scale deployment of KI is safe;3. The Three Mile Island experience has shown us that it is not easy to obtain

a good supply of KI in an emergency;4. The shelf life of properly packaged KI is extremely long;5. The advantage of having a supply on hand for immediate use far outweighs

its moderate cost;6. The problems attendant on predistribution are immaterial for the matter of cre-

ating a stockpile;7. No one questions the ability of KI to protect the thyroid from radio iodine;8. Even though KI administration before any exposure is ideal, the Chernobyl ex-

perience also has shown us that the exposure can continue for days; institution ofKI blockade at any time in this period is beneficial.’’

As cancers go, thyroid cancer is one of the better ones to have—the fatality rateis about five percent in children and ten percent in adults. But no cancer is good,and the 1,200 or so Americans who die of the disease each year are just as deadas those who die of statistically more lethal types of cancer. Moreover, even forthose who survive the disease, it can have major adverse effects on the quality oflife.

65

2 To combat retardation caused by diet-related hypothyroidism (from iodine deficiency), theKennedy Foundation, headed by Mrs. Eunice Kennedy Shriver, has been doing extraordinarilyvaluable and effective work in the Third World to promote iodization of salt. If there is a morecost-effective health program anywhere—vast numbers of people protected at minimal cost—Iam unaware of it.

You get to see a lot of fallout-caused disease in the Marshall Islands, the CentralPacific island group that includes Bikini and Eniwetok, where the United Statestested 67 atomic and hydrogen devices in the 1940’s and 1950’s. I was an adminis-trative judge there in 1991 and 1992, serving as a member of the Nuclear ClaimsTribunal, which administers compensation to Marshallese citizens harmed by thebomb tests.

By far the major health effect of the bombs exploded in the Marshalls has beenmany hundreds of cases of thyroid disease. This includes cancer, benign nodules,and hypothyroidism. The last of these deserves special mention. Hypothyroidism—underactivity of the thyroid—can cause irreversible retardation in children.2 Whenthat happens, the results are tragic.

As for hypothyroidism in adults, a standard medical textbook on the thyroid de-scribes it as ‘‘one of the most insidious’’ of all illnesses. Why? Because it can developso gradually and subtly that no one—not the sufferer, not the family—realizes thatthere is a treatable medical problem.

In the Marshalls, for example, I was once presenting a compensation award to awoman from Eniwetok, and as a courtesy, asked her if there was anything shewanted to say. Yes, she said, her life was miserable: she was always cold. ‘‘Cold?’’I asked, in some astonishment, for the Marshalls are near the Equator, and the cli-mate is torrid and steamy all year round. ‘‘Yes,’’ she said, ‘‘even with my electricblanket on high I shiver and shake all night long.’’

It took only a few more questions to establish that she had all the classic symp-toms of hypothyroidism—thyroid insufficiency. A Tribunal doctor tested her and pre-scribed synthetic thyroid hormone, and before long she was living a normal life. Butfor her, many years of her life had been blighted unnecessarily. There are undoubt-edly people very much like her in this country too—people who are chronically cold,weak, and fatigued, who might be living normal lives if they and their families andtheir doctors knew what to look for.

If ever there is a major nuclear accident in this country, there will probably bemany more such people, with illnesses that might have been prevented by a dime’sworth of medication sitting on the shelf of a hospital or fire station.

The Food and Drug Administration KI ‘‘safe and effective’’ for use in nuclear acci-dents some 20 years ago. The drug works by saturating the thyroid with iodine ina harmless form, thereby ‘‘blocking’’ it against the absorption of inhaled or ingestedradioactive iodine. It has a shelf life of at least five years, and costs approximatelyten cents for each person protected. The NRC’s technical staff estimated in 1994that a supply sufficient to protect the combined population around all U.S. nuclearplants could be purchased for a total of a few hundred thousand dollars—and in-deed, that it would be cheaper to buy stockpiles of the drug than go on studyingwhether to do so.

That would seem to be the very definition of a ‘‘no-brainer.’’Nevertheless, official U.S. policy still holds that it is more ‘‘cost-effective’’ to take

a chance, and treat the cancers if and when they occur, than to spend even thattiny amount on prevention.

The pressing need for stockpiling KI first became apparent during the Three MileIsland accident, in 1979. As this Subcommittee’s Chairman no doubt rememberswell, the fate of the plant hung in the balance for several nerve-wracking days.While reactor operators and Nuclear Regulatory Commission (NRC) officials foughtto bring the plant under control, federal and state officials, fearing a major releasethat would disperse radioactive iodine from the reactor core into the atmosphere,searched for supplies of KI and discovered that they did not exist. A pharmaceuticalcompany executive, responding to a middle-of-the-night plea from the Food andDrug Administration, started up the KI production line at 3 o’clock in the morning.Supplies of the drug were in Pennsylvania 24 hours later. Although the plant expe-rienced a partial core meltdown, the accident fortunately was brought under controlwithout the KI being needed—that time.

Afterwards, the President’s Commission on the Accident at Three Mile Island,headed by John Kemeny, was scathing in condemning the Government’s failure tokeep supplies of the drug available. Stockpiling, it said, was long overdue, and itrecommended prompt corrective action.

The NRC strongly endorsed that recommendation, and promised to make KI amandatory part of emergency planning for every nuclear power plant. The Federal

66

Emergency Management Agency (FEMA) made plans to buy national stockpiles ofthe drug.

In the fall of 1982, however, FEMA and the NRC technical staff, in the space ofjust a few weeks, reversed themselves—180 degrees. FEMA dropped KI from itsbudget, and the NRC technical staff hastily withdrew a pro-KI paper that it hadsent to the NRC Commissioners and replaced it with a paper negative on KI. Why?The reasons were not given, but the circumstances suggest strongly that politics,and pressure from the nuclear industry, won out over health and safety.

In 1983, at a briefing for the Commissioners and the public, senior NRC staff offi-cials explained their new anti-KI position. The nuclear accidents in which KI wouldbe useful were so rare, they said, and the consequences of a radiation-caused thyroid‘‘nodule’’ were so slight, that it would be cheaper to treat such disease after it oc-curred than to prevent it. One of the briefers was the Commission’s Executive Direc-tor for Operations—the head of the NRC’s technical staff—who offered the view thatthe staff’s position was ‘‘courageous.’’

The NRC Chairman, Nunzio Palladino, was skeptical of the briefers’ presentation.He commented that if he survived an accident because of twenty cents’ worth of KI,he would think it ‘‘small change compared to the risk.’’ One of the staff membersquickly corrected him, explaining that ‘‘the surviving question is not the question.’’Rather, he said, the issue was one of ‘‘averting an illness.’’ The briefers made thisillness sound quite trivial, explaining: ‘‘There’s a few days’ loss from—it’s a rel-atively simple operation that’s involved in removing the thyroid or removing thenodules.’’ Another briefer compared KI to an ‘‘amulet,’’ and to an insurance policythat when read carefully, turns out to offer protection only against death by stam-peding elephant.

Given that some 40 percent of radiation-caused nodules are cancerous, and that5 to 10 percent of the cancers are fatal, what the briefers were telling the NRCChairman—their boss—was poppycock. Only much later was it explained that in re-ferring to ‘‘nodules,’’ they meant benign nodules only.

This was as though you offered a public briefing on the value of seat belts in caraccidents without mentioning that you were defining ‘‘accidents’’ as collisions occur-ring at under 5 miles per hour. For compared to cancer, a benign thyroid noduleis a fender-bender. And the briefers never discussed cancer at all.

The NRC staff was successful in winning over the Commissioners, and the ulti-mate result was a 1985 Federal policy statement, still in place today, declaring it‘‘not worthwhile’’ to require KI stockpiling. Thus the recommendation of the KemenyCommission was quietly disposed of, at a time when memories of Three Mile Islandhad faded—except, perhaps, in Pennsylvania—and thoughts of nuclear accidentswere far from most people’s minds.

It did not take long, however, for the Government’s folly and irresponsibility tobe revealed. In April 1986, just 9 months after the policy statement was issued; theChernobyl accident sent a cloud of radioactive iodine and other fallout across Eu-rope. Inhaled and also ingested, through milk and vegetables, the radioactive iodinelodged in the thyroids of children and adults. In 1991, doctors in the vicinity ofMinsk, in Belarus, began to see a pattern of increasing numbers of cases of child-hood thyroid cancer.

The medical crisis in the former Soviet Union is far from over. The number ofchildhood cancers continues to rise, and in addition, the latency period for adult thy-roid cancer is longer than for children, so we can expect to see new thyroid cancersappearing in the Chernobyl-affected areas even 30 or more years from now.

Why did Chernobyl and the cancers resulting from it not turn U.S. policy around?In an ideal world, they would have: The Federal Government would immediatelyhave acknowledged that the President’s Commission on Three Mile Island had beenright all along about KI, and would promptly have made stockpiling a reality. Butthat didn’t happen, perhaps because an admission of error might have raised awk-ward questions about why the recommendations of the President’s Commission hadbeen ignored in the first place. So the Government hunkered down, saying anddoing nothing that would have raised public awareness of the KI issue. It is hardto escape the conclusion that protecting bureaucrats from embarrassment took pri-ority over protecting children from cancer.

In the years since Chernobyl, stockpiling of KI has become routine in countriesaround the world. In April 1996, there was an international conference in Viennaon the health effects of the disaster. An American radiologist described the epidemicof childhood thyroid cancer as a ‘‘completely preventable problem,’’ and said that theuse of KI ‘‘ought to be No. 1 on the list’’ of the lessons of Chernobyl. He lamentedthat his own country continued to lag behind in protecting its people.

The Government’s silence ensures that most Americans are in the dark. Just lastyear, on the 10th anniversary of Chernobyl, a Congressional resolution called on the

67

3 President Bush, and Mrs. Bush as well, had Graves’ disease, in which the thyroid is overac-tive. It is an indication of how subtle and hard to detect thyroid problems can be that the Presi-dent’s extreme hyperthyroidism was not even noticed until it caused him to collapse and be hos-pitalized.

President to make sure that the health lessons learned from Chernobyl were madeavailable to nations around the world. Congress clearly assumed that the U.S. wasin the lead in applying the lessons of Chernobyl; I suspect that those who voted forthe resolution would be quite surprised to discover that we are actually at the backof the pack. They might well ask why, if the Poles can afford to keep 90 milliondoses of KI on the shelf, we can’t manage to do as well by our children.

Is this a disease so trivial that it is not worth preventing? Ask some patients.They will tell you that thyroid cancer can have major effects on the quality of life.First, patients must take synthetic thyroid hormone daily for the rest of their lives,which for many is a serious economic burden. In preparation for diagnostic proce-dures and radiation treatments, moreover, they must switch for several weeks to adifferent thyroid hormone, with different physiological and psychological effects.Then they must stop taking medication altogether, which results in hypothyroidism.In this state, the patient—like the Marshallese woman I described—is weak, chron-ically fatigued, and abnormally sensitive to cold, often shivering uncontrollably intemperatures that others in the same room find comfortable. After treatment, thepatient needs to be reintroduced to medication, which for many is a difficult process,because there is great variation from one person to the next in the amount of hor-mone that the body needs.

The result of these various changes often is a physical and emotional roller-coast-er lasting weeks or months. Does anyone remember when President George Bushcould not speak in public without dissolving in tears? It was just the ups-and-downsof a thyroid patient, getting back on medication after a radiation treatment.3 Somepeople never succeed in making the adjustment. The widow of a member of thisbody, the late Senator John East of North Carolina, was quoted as saying that itwas his doctors’ inability to get his thyroid medication in proper balance that drovehim to take his own life.

Thyroid cancer, in sum, though it is usually curable—emphasis on ‘‘usually’’—andthough there are many much worse illnesses, nevertheless can be extremely dis-agreeable. It is also frightening to have any cancer. (If there are people who do notfind it frightening, they are braver than I am, or dumber.) Is it worth preventing,if we can do so cheaply? Of course it is.

Twice in recent years the Government has come close to rectifying its long failureto ensure KI stockpiling. In 1994, responding to a ‘‘differing professional opinion’’that I had filed 5 years earlier, the NRC staff at last acknowledged that KI stock-piling was a ‘‘prudent’’ measure, and recommended a change in Federal policy. TheNRC staff estimated that a few hundred thousand dollars would buy a stockpile ofthe drug sufficient for the entire country.

Senators Joseph Lieberman and Alan Simpson—an Eastern Democrat and aWestern Republican—weighed in on the issue, writing a letter to the NRC thatmade compelling arguments for stockpiling KI. (A copy is attached to this state-ment.) The Senators pointedly reminded the Commissioners of the Government’s‘‘moral responsibility to provide the public with complete and accurate informationregarding the risks from federally licensed activities and ways in which those risksmay be reduced.’’

But their bipartisan advice was not taken. The NRC Commissioners divided 2 to2, and under NRC rules, a tie vote on a staff proposal means the proposition fails.The old policy stayed in place, and the public remained no wiser than before.

This year the issue was back before the NRC. On June 30, the Commissionersvoted 3–2 in favor of a proposal under which the Federal Government would fundthe cost of KI pills for any state requesting them. The two dissenters, who thoughtthe majority had not gone far enough, were the Commission’s newest members, NilsJ. Diaz, a Republican, and Edward McGaffigan, Jr., a Democrat. They voted tomake KI stockpiling a mandatory part of NRC emergency planning regulations.

The Commission majority’s approach sounds better than it is. Most states, havingbeen assured by the Federal Government for 15 years that KI is undesirable, do notrealize that it could be useful. So far, the NRC has not yet been willing to say outloud that stockpiling KI is a prudent and sensible measure, and to recommend inso many words that states avail themselves of the free KI. Will states and the publicunderstand what the stakes are, when the July 1 NRC press release announcingthe majority’s decision did not even mention the word ‘‘cancer?’’ This was com-parable to announcing the availability of ‘‘Sabin vaccine’’ without mentioning thatits purpose is to prevent polio.

68

4 In fairness to the Commission, I should note that it specifically reserved judgment on wheth-er to grant a petition for rulemaking, filed by me, that would have amended NRC’s emergencyplanning rules to require facility emergency plans to make provision for evacuation, sheltering,and KI. Thus the Commission has not yet completed action on the KI issue, and it should notbe assumed that it is close-minded on the subject.

5 Curiously, the identical language appeared in the statement submitted separately by a rep-resentative of the state of South Carolina.

Moreover, the majority’s approach relies on the fact that the Government plansto establish caches of medicines and supplies in 27 cities as a defense against terror-ism. KI will be among those medicines. But with no indication as to the amountsof stockpiled KI, or their locations, it is not realistic to expect that these stockpileswill be useful for nuclear power plant accidents, when there has been no planningat the state and local level to use the drug.4

In Canada, nuclear utilities support stockpiling of KI in part because they con-sider it good public relations to show that they leave no stone unturned in protect-ing the public. The U.S. nuclear industry, on the other hand, has fought stockpilingadamantly, in part because—as it openly admits—it thinks that KI will make thepublic more apprehensive about nuclear power.

The vacuum of leadership from the Federal Government on the KI issue has ledsome states to explore the question for themselves. Last winter, the Maine AdvisoryCommission on Radiation voted unanimously to recommend stockpiling of KI inevacuation centers near the state’s only nuclear plant, and the Governor acceptedthat recommendation. Maine joins Tennessee and Alabama, which have long main-tained supplies of the drug. New York and now Ohio have begun looking into theissue.

All too many states, however, remain steadfast in their opposition to KI—an oppo-sition often grounded in ignorance of basic facts. For example, in 1996, at a meetingat the Federal Emergency Management Agency on the subject, a representative ofthe Illinois Department of Nuclear Safety justified his opposition to KI by declaring,‘‘Loss of the thyroid is not life-threatening.’’ 5

The quoted statement is true only in the same limited sense in which it is truethat loss of a breast is not life-threatening. For the cancer that causes you to loseyour thyroid, or your breast, can kill you. If the officials of Illinois and South Caro-lina still do not know that, it is a reflection of how badly the federal agencies havefailed in their duty of giving states accurate and complete information.

Can taking KI during an accident prevent all the health effects I have described?Yes, if you can get it to people in time. But can you get it to people in time? Thatmay depend on the circumstances of the event. There is no guarantee you will getit to everyone. But if there are no KI stockpiles, then it is guaranteed that you won’tget it to anyone.

The question that readers may be asking by now is this: If the case for KI is ascompelling as I have suggested, what are the arguments against it? The argumentsone hears against KI fall into two classes. First, there are those that are just plaininvalid—factually incorrect. The second are the objections that although they maybe factually correct—for example, that evacuation is generally the best option—arestill not a good reason to be without KI stockpiles.

I will start with the invalid arguments, which number six.1. There is no new data challenging existing policy.—In fact, there is a wealth of

new data since Chernobyl, such as the presentations at the April 1996 conferencementioned earlier, suggesting that airborne radiolodines are more dangerous to chil-dren’s thyroids than previously suspected. But even if there were no new data, theexisting policy was defective from the start, because it was based on misinformation.

2. Loss of the thyroid is not life-threatening.—A March 1996 publication of the nu-clear industry’s own lobbying group, the Nuclear Energy Institute, reported 550cases of childhood thyroid cancer in the former Soviet Union, with five fatalities.(The numbers are higher now.) If it’s life-threatening in Minsk, it’s life-threateningin Mason City and Middletown. In any case, who says a disease has to be life-threatening to be worth preventing? That’s not the standard we use when we haveour kids immunized against mumps, measles, and chicken pox.

3. KI is not cost-effective.—KI is an insurance policy—backup protection in caseof certain events that are unlikely but have serious consequences when they dooccur. Is it ‘‘cost-effective?’’ The problem with framing the issue that way is that ifby ‘‘cost-effective’’ you mean ‘‘likely to pay for itself over time,’’ no insurance policymeets that test. The insurance companies would all be bankrupt if they didn’t takein more from the average buyer than they pay out. Rational people, when decidingwhether insurance is worthwhile, don’t ask whether it is sure to pay for itself, but

69

whether it provides valuable protection at a reasonable cost. Stockpiling of KI meetsthat test.

4. KI could complicate evacuation.—You sometimes hear the argument that KIwill diminish safety in an emergency, because people will ignore evacuation ordersand go looking for KI instead. That’s very farfetched. In fact, if you wanted to en-courage evacuation, you might want to tell people over radio and television thatwhen they get to the evacuation center, they will be checked out medically andgiven a medicine, potassium iodide, that will help protect them against radiation.And you add that this drug will not be available locally. So KI should not be a hin-drance to an orderly evacuation; it might even be an incentive.

5. KI carries a risk of serious side effects.—The best data on side effects comesfrom the Polish experience after Chernobyl, which is documented in a medical jour-nal article co-written by a Polish health official and an NIH scientist. The Polesgave out 18 million doses. Two people were hospitalized, briefly. Both of them hadknown iodine allergies and took the drug in spite of being warned not to. Our ownFDA says the benefit outweighs the side effects. The doctors of the American Thy-roid Association were well aware of the side effects issue when they unanimouslyendorsed stockpiling in November 1996.

6. KI could increase state’s risk of liability.—Distribution of KI would take placeonly after an advisory from the federal government that it was appropriate. In thatsituation, with a state following federal directives and doing the best it could underemergency conditions, who would find a state liable? If I were a state, I would bemuch more worried about the consequences of not having a KI stockpile, given allthat is known about the drug’s value. If ever there were an accident, and it turnedout a state had no KI to give out because it had taken its medical advice from lobby-ists instead of doctors, that would be the time to worry about liability.

The following are six arguments I consider factually accurate, but still not persua-sive reasons to forgo stockpiling.

7. Evacuation is preferable.—The most common argument against KI is also themost meritless: that evacuation is better, so we don’t need KI and shouldn’t evenhave it around as a precaution. The problem is that evacuation isn’t always feasible.The NRC and FEMA have never claimed it was. KI is backup protection—Plan B—for those situations where evacuation cannot be completed in time to avoid a sub-stantial radiation dose to the thyroid—for example, because of adverse weather con-ditions, blocked roads, or widely dispersed radioactivity. Also, people may be ex-posed to radiation while they are evacuating—automobiles don’t afford much protec-tion.

Moreover, it is not an either/or proposition. You don’t choose between backingevacuation and backing stockpiling of KI; you do both. The question is whether youhave three weapons in your arsenal—evacuation, sheltering, and KI—or only two,in a situation when the third weapon costs only a pittance.

The lifejackets on a ferryboat are a pretty close parallel to KI. Are ferryboat disas-ters common? No. Is the lifejacket the best way of escaping harm if a ferry sinks?No, you’re better off being evacuated by lifeboat or helicopter—if that is possible.But does that mean we should dispense with lifejackets? Of course not. We havelifejackets because in the rare instance in which you need them, you are in gravedanger without them. So we have lifeboats and lifejackets, because it’s the sensibleand prudent thing to do.

8. Big accidents are unlikely.—It is true that big accidents are unlikely. Generallyspeaking, a combination of good design, good operation, and good regulation makesAmerican nuclear reactors quite safe. But there is a big difference between sayingthat accidents are unlikely and saying that they cannot happen. If we could be surethat accidents would not happen, then all emergency planning—sirens, drills, andthe like—could go out the window. The cost of KI is a drop in the bucket by com-parison to what is already spent on emergency preparedness. The reason we havesirens and drills and the rest is that we know that accidents can happen. (So canacts of terrorism.) If we accept the idea that emergency preparedness makes sense,then our preparedness ought to be first-rate, not second-rate.

9. Public confidence in the technology could be affected.—That is a quotation froman industry ‘‘White Paper’’ on KI that was sent to the Nuclear Regulatory Commis-sion in 1993. The same argument could be made to assert that we shouldn’t havecontainments or emergency core cooling systems at nuclear plants, since both ofthose structures might remind people that accidents can happen.

You don’t hear the ferryboat operators complaining that having lifejackets onboard will diminish confidence in ferryboat technology. If I were the industry, Iwould be embracing KI, and making the point that even though it is very unlikelythat it would ever be needed, the industry is committed to ensuring that Americansare protected to the highest standard in the world.

70

10. The logistics of distribution need more study.—The opponents of KI stockpilingsometimes try to change the subject from whether KI is a valuable protective meas-ure (an argument they know they will lose) to the logistics of delivering the drugin an emergency. The idea is to make the delivery of KI sound just impossibly com-plicated, so as to put off, preferably forever, the question of whether it makes senseto have the drug at all. Those arguments were made at the June 1996 meeting atFEMA, and answered by Dr. Jacob Robbins of the National Institutes of Health,whom I quoted earlier. He observed that there were two issues: whether to stockpileKI, and how to deliver it to people in an emergency. He said:

‘‘You’re sort of asking the question: Which should come first? If you rememberback to the Three Mile Island incident, there was no stockpile. It was requested.With a great deal of difficulty, in a rather inadequate way, it was finally madeavailable. And it was ready to be used but with a delay. I think we have to thinkof both aspects. And what the American Thyroid Association has said is create thestockpiles, have them available, and then have expert groups developing the mecha-nisms of how to distribute this in time of need.’’

It’s hard to quarrel with that advice: make the decision in principle that havingKI makes sense, establish stockpiles, and then work out the logistics of how youwant to distribute it. While you are thinking about logistics, the drug can be onsitein schools, or hospitals, or fire stations, or all three.

11. The states don’t want it.—This is an argument you hear again and again atthe federal level. The Federal Government has been giving the states inaccurate andincomplete information about KI for 15 years, and it is small wonder that many ofthem believe that KI is undesirable. Once states begin to get full and up-to-date in-formation about KI, their attitude toward stockpiling is likely to change, as Maine’sdid.

12. People can buy it for themselves.—The argument can be made that people arefree to buy the drug for themselves, and that the states and the Federal Govern-ment should not be involved. First, the drug is unlikely to be available locally. Sec-ond, people will know to buy the drug only if the authorities accept the obligationof informing them. It would probably be cheaper to buy a stockpile than to take onthe task of telling people that they should consider buying it. Third, in an emer-gency, some people—such as schoolchildren—will not be at home. Fourth, do youreally want to say that for the people who didn’t have the foresight or money tobuy the drug, it’s their tough luck?

To leave it up to individuals would be like telling ferryboat passengers that theyare free to bring their own lifejackets. It’s simpler, fairer, and better health policyto stockpile KI and bring it out for the entire affected population in time of need.

In conclusion, Americans have a right, where nuclear hazards are involved, to ex-pect their Government to ensure that they are protected adequately and that theyare given accurate and complete information. In the case of potassium iodide, theGovernment has so far done neither. It is high time that the Federal Governmentlived up to its responsibilities, so that we can at last say that American childrenenjoy radiation protection second to none.

Thank you.Attachment:

LETTER FROM SENATORS JOSEPH I. LIEBERMAN AND ALAN K. SIMPSON

U.S. SENATE,COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS,

Washington, DC, April 20, 1994.Hon. IVAN SELIN,Chairman, U.S. Nuclear Regulatory Commission,Washington, DC.

DEAR CHAIRMAN SELIN: We are writing to urge the Nuclear Regulatory Commis-sion (NRC) to revise its current policy regarding the availability and use of potas-sium iodide (KI) in the event of an emergency at a nuclear power plant.

The NRC’s current policy is that state and local governments should considerstockpiling KI for emergency use by emergency workers and institutionalized per-sons, but not for the general public. This policy was established in the early 1980’s.Since that time, however, new information has arisen and additional experience hasbeen gained on the costs and benefits of the prophylactic use of KI by the generalpopulation. We believe that this new information and experience requires a new ap-proach to this issue.

It is well established scientifically that KI is extremely effective in preventing theuptake of radioactive iodine by the thyroid. If taken in the proper dose prior to expo-

71

sure to radioactive iodine KI can completely block the uptake of the radioactive io-dine.

The distribution of KI to the general population in the event of nuclear emergencyis a widely accepted protective measure. The World Health Organization has rec-ommended its use for people living near a nuclear power plant if radiation levelsare expected to exceed a predetermined dose. A number of foreign governments—including the United Kingdom, the Czech Republic, Switzerland, Canadian prov-inces with nuclear power plants, and the former Soviet Union—stockpile KI for dis-tribution to and use by the general public in the event of a nuclear emergency. Inthe United States, three States—Alabama, Tennessee, and Arizona—have plans todistribute or already have distributed KI to people living near one or more nuclearpower plants within those States.

A recent cost-benefit study of this issue conducted for NRC indicates that thecosts of stockpiling KI for people who live within five miles of a nuclear power plantare minimal—approximately 10 cents per person per year. This means that for atypical population of 10,000 people living within five miles of a nuclear power plant,it would cost approximately $1,000 to make KI available for distribution. The NRCstaff projects that the cost of stockpiling KI for everyone in the country within fivemiles of a nuclear power plant would be on the order of several hundred thousanddollars per year. This is only a small fraction of the expenses already spent on emer-gency planning. As the NRC staff has noted, ‘‘[c]osts in this range present no signifi-cant barrier to stockpiling and are probably less than the cost of the continued stud-ies.’’

Some concern has been expressed that public education on the use of KI may re-sult in a potentially significant negative public perception. However, no evidencehas been provided that any of the existing policies in other nations or in the Statesthat provide for the use of KI by the general population has caused any undue panicor apprehension to the general public. Moreover, the Federal Government has amoral responsibility to provide the public with complete and accurate informationregarding the risks from federally-licensed activities and ways in which those risksmay be reduced.

In sum, therefore, KI can be an extremely effective countermeasure to preventdamage to the thyroid in the event of a radiological emergency. It can also be madeavailable for the general population living near a nuclear power plant for minimalcosts. The NRC should revise its policy to provide this additional potential protec-tive measure for nuclear emergency planning.

We thank you for your time and consideration.Sincerely,

ALAN K. SIMPSON,Ranking minority member, Sub-

committee on Clean Air and Nu-clear Regulation.

JOSEPH I. LIEBERMAN,Chairman, Subcommittee on Clean

Air and Nuclear Regulation.

CONCLUSION OF HEARING

Senator HARKIN. Anything else before we close the meetingdown? Dr. Klausner, any final last observations or requests, advice,to this committee?

[No response.]Senator HARKIN. If not, we thank you all very much for your

time and for your information, that concludes our hearing. The sub-committee will stand in recess subject to the call of the Chair.

[Whereupon, at 10:40 a.m., Wednesday, October 1, the hearingwas concluded, and the subcommittee was recessed, to reconvenesubject to the call of the Chair.]

Æ